Pulmonary rehabilitation for chronic obstructive pulmonary disease

  • Review
  • Intervention

Authors


Abstract

Background

Widespread application of pulmonary rehabilitation (also known as respiratory rehabilitation) in chronic obstructive pulmonary disease (COPD) should be preceded by demonstrable improvements in function (health-related quality of life, functional and maximal exercise capacity) attributable to the programmes. This review updates the review reported in 2006.

Objectives

To compare the effects of pulmonary rehabilitation versus usual care on health-related quality of life and functional and maximal exercise capacity in persons with COPD.

Search methods

We identified additional randomised controlled trials (RCTs) from the Cochrane Airways Group Specialised Register. Searches were current as of March 2014.

Selection criteria

We selected RCTs of pulmonary rehabilitation in patients with COPD in which health-related quality of life (HRQoL) and/or functional (FEC) or maximal (MEC) exercise capacity were measured. We defined 'pulmonary rehabilitation' as exercise training for at least four weeks with or without education and/or psychological support. We defined 'usual care' as conventional care in which the control group was not given education or any form of additional intervention. We considered participants in the following situations to be in receipt of usual care: only verbal advice was given without additional education; and medication was altered or optimised to what was considered best practice at the start of the trial for all participants.

Data collection and analysis

We calculated mean differences (MDs) using a random-effects model. We requested missing data from the authors of the primary study. We used standard methods as recommended by The Cochrane Collaboration.

Main results

Along with the 31 RCTs included in the previous version (2006), we included 34 additional RCTs in this update, resulting in a total of 65 RCTs involving 3822 participants for inclusion in the meta-analysis.

We noted no significant demographic differences at baseline between members of the intervention group and those who received usual care. For the pulmonary rehabilitation group, the mean forced expiratory volume at one second (FEV1) was 39.2% predicted, and for the usual care group 36.4%; mean age was 62.4 years and 62.5 years, respectively. The gender mix in both groups was around two males for each female. A total of 41 of the pulmonary rehabilitation programmes were hospital based (inpatient or outpatient), 23 were community based (at community centres or in individual homes) and one study had both a hospital component and a community component. Most programmes were of 12 weeks' or eight weeks' duration with an overall range of four weeks to 52 weeks.

The nature of the intervention made it impossible for investigators to blind participants or those delivering the programme. In addition, it was unclear from most early studies whether allocation concealment was undertaken; along with the high attrition rates reported by several studies, this impacted the overall risk of bias.

We found statistically significant improvement for all included outcomes. In four important domains of quality of life (QoL) (Chronic Respiratory Questionnaire (CRQ) scores for dyspnoea, fatigue, emotional function and mastery), the effect was larger than the minimal clinically important difference (MCID) of 0.5 units (dyspnoea: MD 0.79, 95% confidence interval (CI) 0.56 to 1.03; N = 1283; studies = 19; moderate-quality evidence; fatigue: MD 0.68, 95% CI 0.45 to 0.92; N = 1291; studies = 19; low-quality evidence; emotional function: MD 0.56, 95% CI 0.34 to 0.78; N = 1291; studies = 19; mastery: MD 0.71, 95% CI 0.47 to 0.95; N = 1212; studies = 19; low-quality evidence). Statistically significant improvements were noted in all domains of the St. George's Respiratory Questionnaire (SGRQ), and improvement in total score was better than 4 units (MD -6.89, 95% CI -9.26 to -4.52; N = 1146; studies = 19; low-quality evidence). Sensitivity analysis using the trials at lower risk of bias yielded a similar estimate of the treatment effect (MD -5.15, 95% CI -7.95 to -2.36; N = 572; studies = 7).

Both functional exercise and maximal exercise showed statistically significant improvement. Researchers reported an increase in maximal exercise capacity (mean Wmax (W)) in participants allocated to pulmonary rehabilitation compared with usual care (MD 6.77, 95% CI 1.89 to 11.65; N = 779; studies = 16). The common effect size exceeded the MCID (4 watts) proposed by Puhan 2011(b). In relation to functional exercise capacity, the six-minute walk distance mean treatment effect was greater than the threshold of clinical significance (MD 43.93, 95% CI 32.64 to 55.21; participants = 1879; studies = 38).

The subgroup analysis, which compared hospital-based programmes versus community-based programmes, provided evidence of a significant difference in treatment effect between subgroups for all domains of the CRQ, with higher mean values, on average, in the hospital-based pulmonary rehabilitation group than in the community-based group. The SGRQ did not reveal this difference. Subgroup analysis performed to look at the complexity of the pulmonary rehabilitation programme provided no evidence of a significant difference in treatment effect between subgroups that received exercise only and those that received exercise combined with more complex interventions. However, both subgroup analyses could be confounded and should be interpreted with caution.

Authors' conclusions

Pulmonary rehabilitation relieves dyspnoea and fatigue, improves emotional function and enhances the sense of control that individuals have over their condition. These improvements are moderately large and clinically significant. Rehabilitation serves as an important component of the management of COPD and is beneficial in improving health-related quality of life and exercise capacity. It is our opinion that additional RCTs comparing pulmonary rehabilitation and conventional care in COPD are not warranted. Future research studies should focus on identifying which components of pulmonary rehabilitation are essential, its ideal length and location, the degree of supervision and intensity of training required and how long treatment effects persist. This endeavour is important in the light of the new subgroup analysis, which showed a difference in treatment effect on the CRQ between hospital-based and community-based programmes but no difference between exercise only and more complex pulmonary rehabilitation programmes.

摘要

慢性阻塞性肺病的肺部復健

背景

廣泛應用於慢性阻塞性肺病(COPD) 的肺部復健(也被稱為呼吸復健),應展現可歸因於復健計畫的改善功能 (包括健康相關生活品質、功能性運動能力及最大運動能力)。本文獻回顧係更新2006年的文獻回顧研究報告。

目的

比較肺部復健和一般照護對慢性阻塞性肺病患者的健康相關生活品質、功能性運動能力和最大運動能力的成效。

搜尋策略

我們自Cochrane Airway Group Specialised Register找到更多隨機對照試驗,搜尋至2014年3月為止。

選擇標準

我們選擇有測量健康相關生活品質(HRQoL)及/或功能性運動能力(FEC)或最大(MEC)運動能力的肺部復健之慢性阻塞性肺病病人的隨機對照試驗。我們定義肺部復健為至少持續4周的運動訓練,不管有無衛教和心理支持。我們定義一般照護為常規照護,其中控制組沒有給予衛教或任何其他形式的介入。有下列情況我們認為參與者係接受為ㄧ般照護:只有給予口頭的建議而無其他的衛教,以及在試驗一開始時因考量什麼是最佳做法,針對所有參與者所做的藥物更改或調整。

資料收集與分析

我們採隨機效應模式計算平均差(MD)。我們向原研究作者徵詢遺漏的資料。我們依據The Cochrane Collaboration所建議的標準方法進行資料收集與分析。

主要結果

包含先前版本(2006年)納入的31個隨機對照試驗,此次更新增加納入34個隨機對照試驗,總計納入65個隨機對照試驗,共包含3822位參與者在此次的統合分析中。

在試驗開始前,介入組和一般照護組兩組受試者間沒有顯著人口學上的差異。對於肺部復健組,平均第一秒用力呼氣量(forced expiratory volume at one second;FEV1) 預測有39.2 %,一般照護組為 36.4 %;平均年齡分別為62.4歲和62.5歲。兩組中的男女性別比約2:1。總共有41個肺部復健計畫是在醫院進行(住院病人或出院病人),23個計畫是於社區進行(在社區中心或病人家中),以及一個研究包含醫院和社區兩部分。大部分的計畫執行12周或8周,全部期間範圍由4周至52周。

介入的性質使得研究人員對受試者或計畫執行者要執行盲法是不可能的。此外,大部分早期的研究是否採取隱密分配也不清楚;且一些研究有的高的流失率,亦對整體的偏差風險有影響。

我們在所有納入的結果均看到有統計上的顯著改善。在生活品質的4個重要面向(慢性呼吸問卷分數(Chronic Respiratory Questionnaire;CRQ)的呼吸困難、疲勞、情緒功能和自覺對疾病的可控性),效果比0.5單位的最小臨床重要差異值(minimal clinically important difference;MCID)大(呼吸困難: 平均差為 0.79, 95 % CI 0.56 至 1.03, 樣本數1283, 19個研究, 證據品質中等;疲勞:平均差 0.68, 95% CI 0.45 至 0.92, 樣本數1291, 19個研究, 證據品質低;情緒功能:平均差0.56, 95% CI 0.34至0.78, 樣本數1291, 19個研究;自覺對疾病的可控性:平均差 0.71, 95% CI 0.47至0.95, 樣本數1212, 19個研究, 證據品質低)。在聖喬治呼吸問卷的所有面向(St. George's Respiratory Questionnaire;SGRQ)均有統計上的顯著改善,總分則有4個單位的改善(平均差 -6.89, 95% CI -9.26 至 -4.52, 樣本數1146, 19個研究, 證據品質低)。以低偏差風險試驗進行敏感性分析亦得到相似的治療效果估算值 (平均差 -5.15, 95 % CI -7.95 至 -2.36, 樣本數 572, 7個研究)。

在功能性運動能力和最大運動能力兩者都顯示有統計上的顯著改善。相較於接受一般照護,分配到肺部復健的受試者,研究顯示有增加其最大運動能力(mean Wmax;W) (平均差 6.77, 95% CI 1.89 至 11.65, 樣本數779, 16個研究)。共通的成效量超過Puhan於2011年提出的MCID (4 瓦)。關於功能性運動能力,6分鐘行走距離的平均治療效果比臨床有顯著意義的閾值大(平均差 43.93, 95% CI 32.64 至 55.21, 參與人數 1879, 38個研究)。http://Puhan 2011(b)

比較於醫院內和社區兩種復健計畫的次群組分析,在慢性呼吸問卷的所有面向均顯示,次群組間有顯著的治療成效差異,一般來說,在醫院進行的肺部復健組比在社區進行的組別之平均值高。SGRQ問卷則沒有顯示這樣的差異。另外,依肺部復健計劃的複雜性進行次群組分析,只做運動和接受運動並結合更複雜的介入措施這兩個次群組間,其治療效果沒有顯著差異的證據。然而,此兩個次群組分析可能有干擾,其結果應該小心地解讀。

作者結論

肺部復健可減緩呼吸困難和疲勞,改善情緒功能以及增進個案對自己疾病狀況的控制感,對病情有中等大且具臨床意義的改善。對於控制慢性阻塞性肺病來說,復健扮演很重要的一部分,有利於增進健康相關生活品質以及運動能力。我們認為在慢性阻塞性肺部疾病進行更多比較肺部復健和傳統照護的隨機對照試驗是沒有必要的,未來研究應該著重在確認肺部復健哪個部分是必要的、其理想的時間長度和地點、指導及所需訓練強度的程度,以及治療效果可以維持多久。本研究的重要在於由新次群組分析上,慢性呼吸問卷評估顯示,在醫院執行和在社區執行的計畫治療效果有差異,在只有做運動和較複雜的肺部復健計畫兩者間則沒有差異。

Resumen

Rehabilitación pulmonar para la enfermedad pulmonar obstructiva crónica

Antecedentes

La aplicación generalizada de la rehabilitación pulmonar (también conocida como rehabilitación respiratoria) para la enfermedad pulmonar obstructiva crónica (EPOC) debe estar precedida por mejorías demostrables en la función (calidad de vida relacionada con la salud, capacidad para el ejercicio funcional y máximo) atribuibles a los programas. Esta revisión actualiza la revisión informada en 2006.

Objetivos

Comparar los efectos de la rehabilitación pulmonar versus la atención habitual sobre la calidad de vida relacionada con la salud y la capacidad para el ejercicio funcional y máximo en pacientes con EPOC.

Métodos de búsqueda

Se identificaron ensayos controlados aleatorios (ECA) adicionales en el registro especializado de ensayos del Grupo Cochrane de Vías Respiratorias (Cochrane Airways Group). Las búsquedas se actualizaron en marzo 2014.

Criterios de selección

Se seleccionaron los ECA de rehabilitación pulmonar en pacientes con EPOC en los que se midió la calidad de vida relacionada con la salud (CdVRS) o la capacidad para el ejercicio funcional (CEF) o máximo (CEM). La "rehabilitación pulmonar" se definió como el entrenamiento con ejercicios durante al menos cuatro semanas con o sin educación y apoyo psicológico. La "atención habitual" se definió como la atención convencional en la que al grupo control no se le proporcionó educación ni cualquier otra forma de intervención adicional. Se consideró que los participantes en las siguientes situaciones recibieron atención habitual: solamente se proporcionó asesoramiento verbal sin educación adicional; y la medicación se modificó u optimizó según lo que se consideró la mejor práctica al comienzo del ensayo en todos los participantes.

Obtención y análisis de los datos

Se calcularon las diferencias de medias (DM) con un modelo de efectos aleatorios. Se solicitaron los datos faltantes a los autores del estudio primario. Se utilizaron los métodos estándar recomendados por la Colaboración Cochrane.

Resultados principales

Junto con los 31 ECA incluidos en la versión anterior (2006), se incluyeron 34 ECA adicionales en esta actualización, lo que resultó en un total de 65 ECA con 3822 participantes para su inclusión en el metanálisis.

No se observaron diferencias demográficas significativas iniciales entre los miembros del grupo de intervención y los que recibieron atención habitual. En el grupo de rehabilitación pulmonar el volumen espiratorio forzado (VEF) medio en un segundo fue del 39,2% del valor teórico, y en el grupo de atención habitual del 36,4%; la media de edad fue 62,4 y 62,5 años, respectivamente. La mezcla de sexos en ambos grupos fue alrededor de dos hombres por cada mujer. Cuarenta y un programas de rehabilitación pulmonar se realizaron en el hospital (pacientes hospitalizados o ambulatorios), 23 fueron comunitarios (en centros comunitarios o en domicilios) y un estudio tuvo un componente hospitalario y un componente comunitario. La mayoría de los programas tuvo 12 semanas u ocho semanas de duración con un intervalo global de cuatro semanas a 52 semanas.

La naturaleza de la intervención hizo que no fuera posible que los investigadores cegaran a los participantes o a los que proporcionaban el programa. Además, no estuvo claro si la mayoría de los estudios más antiguos realizó ocultación de la asignación; lo que junto con las tasas altas de desgaste informadas por varios estudios repercutió en el riesgo general de sesgo.

Se encontraron mejorías estadísticamente significativas en todos los resultados incluidos. En cuatro dominios importantes de calidad de vida (CdV) (puntuaciones del Chronic Respiratory Questionnaire [CRQ] para la disnea, la fatiga, la función emocional y la destreza), el efecto fue mayor que la diferencia mínima clínicamente importante (DMCI) de 0,5 unidades (disnea: DM 0,79; intervalo de confianza [IC] del 95%: 0,56 a 1,03; n = 1283; estudios = 19; pruebas de calidad moderada; fatiga: DM 0,68; IC del 95%: 0,45 a 0,92; n = 1291; estudios = 19; pruebas de baja calidad; función emocional: DM 0,56; IC del 95%: 0,34 a 0,78; n = 1291; estudios = 19; destreza: DM 0,71; IC del 95%: 0,47 a 0,95; N = 1212; estudios = 19; pruebas de baja calidad). Se observaron mejorías estadísticamente significativas en todos los dominios del St. George Respiratory Questionnaire (SGRQ), y la mejoría en la puntuación total fue mejor que 4 unidades (DM -6,89; IC del 95%: -9,26 a -4,52; N = 1146; estudios = 19; pruebas de baja calidad). El análisis de sensibilidad con los ensayos con menor riesgo de sesgo produjo una estimación similar del efecto del tratamiento (DM -5,15; IC del 95%: -7,95 a -2,36; n = 572; estudios = 7).

El ejercicio funcional y el ejercicio máximo mostraron una mejoría estadísticamente significativa. Los investigadores informaron un aumento en la capacidad para el ejercicio máximo (media Wmax [W]) en los participantes asignados a rehabilitación pulmonar en comparación con atención habitual (DM 6,77; IC del 95%: 1,89 a 11,65; n = 779; estudios = 16). El tamaño común del efecto excedió la DMCI (4 vatios) propuesto por Puhan 2011(b). Con relación a la capacidad para el ejercicio funcional, el efecto medio del tratamiento de distancia de caminata de seis minutos fue mayor que el umbral de significación clínica (DM 43,93; IC del 95%: 32,64 a 55,21; participantes = 1879; estudios = 38).

El análisis de subgrupos que comparó los programas en el hospital versus los programas comunitarios, proporcionó pruebas de una diferencia significativa en el efecto del tratamiento entre los subgrupos en todos los dominios del CRQ, con valores medios mayores, como promedio, en el grupo de rehabilitación pulmonar en el hospital que en el grupo comunitario. El SGRQ no mostró esta diferencia. El análisis de subgrupos realizado para analizar la complejidad del programa de rehabilitación pulmonar no aportó pruebas de una diferencia significativa en el efecto del tratamiento entre los subgrupos que recibieron ejercicio solamente y los que recibieron ejercicios combinados con intervenciones más complejas. Sin embargo, ambos análisis de subgrupos podrían estar sujetos a confusión y se deben interpretar con cuidado.

Conclusiones de los autores

La rehabilitación pulmonar alivia la disnea y la fatiga, mejora la función emocional y mejora el sentido del control que los individuos tienen sobre la enfermedad. Estas mejorías son moderadamente grandes y clínicamente significativas. La rehabilitación sirve como un componente importante del tratamiento de la EPOC y tiene efectos beneficiosos al mejorar la calidad de vida relacionada con la salud y la capacidad de ejercicio. Se considera que no se justifica la realización de ECA adicionales que comparen la rehabilitación pulmonar y la atención convencional en la EPOC. Los estudios de investigación futuros se deben centrar en la identificación de los componentes fundamentales de la rehabilitación pulmonar, la duración y la ubicación ideales, el grado de supervisión y la intensidad de entrenamiento necesario, y el tiempo en el que persisten los efectos del tratamiento. Este esfuerzo es importante luego del nuevo análisis de subgrupos que mostró una diferencia en el efecto del tratamiento sobre el CRQ entre los programas en el hospital y comunitarios, pero que no mostró diferencias entre el ejercicio solo y los programas de rehabilitación pulmonar más complejos.

摘要

慢性阻塞性肺病的肺部康复

研究背景

广泛应用于慢性阻塞性肺病的肺部康复(又称呼吸康复)应当优于功能性的改善(健康相关的生活质量、功能性运动能力和最大运动能力)。此综述是对发表于2006年的综述的更新。

研究目的

比较肺部康复与常规治疗对慢性阻塞性肺病人群的健康相关生活质量、功能性运动能力和最大运动能力的影响。

检索策略

我们在Cochrane呼吸道组专业注册库(Cochrane Airways Group Specialised Register)检索到了更多的随机对照试验。检索止于2014年3月。

标准/纳入排除标准

我们纳入了对慢性阻塞性肺病康复患者测量健康相关的生活质量或功能性运动能力或最大运动能力的随机对照试验。我们定义“肺部康复”为为期4周以上的康复训练(不管是否包含教育或心理支持)。我们定义“常规治疗”为不给予教育或任何其它形式的干预的传统治疗(作为对照组)。有下列情况的受试者被认定为常规治疗:只给予口头建议而没有其它额外的教育;试验开始时因考量什么是最佳做法而调整或优化用药的 受试者。

数据收集与分析

我们用随机效应模型计算平均差。我们向原研究作者索要缺失数据。我们应用的标准方法源于Cochrane协作网的推荐。

主要结果

除了上一版本综述(2006年)纳入的31项随机对照试验,我们这次追加了34项,所以此综述共纳入65个随机对照试验3822名受试者进行Meta分析。

康复组和常规治疗组之间的基线没有显著的人口统计学差异。肺部康复组的平均1秒用力呼气量(FEV1)预测是39.2%,常规治疗组为36.4%;平均年龄分别是62.4岁和62.5岁。两组男女性别比例约为2:1。41项肺部康复项目在医院进行(住院或门诊),23项在社区进行(社区中心或家里),1项研究既有医院又有社区。纳入研究的治疗周期为4周至52周不等,其中大部分项目为期12周或8周。

干预的性质决定了研究人员无法对受试者或项目执行者致盲。此外,大部分早期研究是否进行了分配隐藏是不清楚的;部分研究的高脱落率也对整体偏倚风险产生影响。

我们发现所有的结果都有统计学意义。生活质量的4个重要部分(慢性呼吸问卷分数:呼吸困难、疲劳、情绪功能和自觉对疾病的掌控)的影响比0.5单位最小临床重要差异更大(呼吸困难:MD=0.79,95%CI=0.56 - 1.03;19项研究1283名受试者;中等质量证据。疲劳:MD=0.68,95%CI=0.45 - 0.92;19项研究1291名受试者;低质量证据。情绪功能:MD=0.56,95%CI=0.34 - 0.78;19项研究1291名受试者。自觉对疾病的掌控:MD=0.71,95%CI=0.47 - 0.95;19项研究1212名受试者;低质量证据)。圣乔治呼吸问卷的所有部分的改善均有统计学意义,总分的改善优于4单位(MD=-6.89,95%CI=-9.26 - -4.52;19项研究1146名受试者;低质量证据)。将低偏倚风险的试验纳入敏感性分析,得出与治疗效果相似的估算值。

功能性运动和最大运动的改善均有统计学意义。相比于常规治疗,接受肺部康复的受试者的最大运动能力(mean Wmax)得以提升(MD=6.77,95%CI=1.89 - 11.65;16项研究779名受试者)。Puhan 2011(b)提出一般效应量优于最小临床重要差异。关于功能性运动能力,6分钟步行距离的平均治疗效果超过临床意义阈值(MD=43.93,95%CI=32.64 - 55.21;38项研究1879名受试者)。

亚组分析对比医院康复和社区康复,医院肺部康复的慢性呼吸问卷的所有部分的治疗效果均明显优于社区康复(更高的平均值)。圣乔治呼吸问卷则没有显示这种差异。依据肺部康复项目的复杂性进行亚组分析,显示只接受训练的亚组和接受训练联合更复杂干预手段的亚组之间并没有显著的差异。然而,两个亚组分析可能被干扰,其结果应当谨慎地解读。

作者结论

肺部康复缓解了呼吸困难和疲劳,改善了情绪功能,增强了自觉对疾病的掌控力。这些中等程度的改善同时具有显著临床意义。康复已成为慢性阻塞性肺病管理的重要组成部分,且有利于改善健康相关的生活质量和运动能力。我们认为更多的对比肺部康复和传统治疗的随机对照试验是没有必要的。未来的研究应当侧重于确定肺部康复的哪些部分是必要的,以及它的理想治疗周期和地点,监督和训练强度的等级和疗效的持续时长。本综述的重点在于新的亚组分析,医院康复与社区康复的疗效存在差异,但只接受训练与训练联合更复杂的肺部康复之间没有差异。

Plain language summary

Pulmonary rehabilitation for chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) describes a chronic lung condition that prevents the air supply from getting to the lungs. Symptoms include breathlessness, coughing, tiredness and frequent chest infection. Worldwide, COPD is a major cause of ill health.

Pulmonary rehabilitation programmes include exercise as a key component; some programmes contain other interventions such as assessment, education, psychological support and dietary advice. Pulmonary rehabilitation is one of the key recommended approaches in the treatment of COPD. This review compared the impact of pulmonary rehabilitation versus usual care on the health-related quality of life of people with COPD. We included 65 studies involving 3822 participants. Participants were randomly assigned to receive pulmonary rehabilitation or usual care. The quality of the studies was generally good.

This review highlights that pulmonary rehabilitation improves the health-related quality of life of people with COPD. Results strongly support inclusion of pulmonary rehabilitation as part of the management and treatment of patients with COPD.

Future studies should concentrate on identifying the most important components of pulmonary rehabilitation, the ideal length of a programme, the intensity of training required and how long the benefits of the programme last.

淺顯易懂的口語結論

慢性阻塞性肺病的肺部復健

慢性阻塞性肺部疾病(COPD)係指因空氣供應到肺部受到阻礙的一種慢性肺部症狀。症狀包含呼吸困難、咳嗽、疲累以及經常性胸腔感染。在全世界中,慢性阻塞性肺病是主要不健康的原因之一。

肺部復健計畫包含一個關鍵部分─運動;有些計畫尚有其他介入措施,如:評估、衛教、心理支持以及飲食建議。肺部復健是治療慢性阻塞性肺病重要的建議方法之一。本篇文獻回顧比較肺部復健和一般照護對慢性阻塞性肺病患者的健康相關生活品質的影響。我們納入65個研究,共包含3822位參與者,參與者隨機被分派至接受肺部復健或一般照護,研究的品質普遍是不錯的。

此文獻回顧指出肺部復健可改善慢性阻塞性肺部疾病患者的健康相關生活品質,本研究結果強烈支持將肺部復健納入為慢性阻塞性肺部疾病 控制及治療的一部份。

未來研究應該專注於釐清肺部復健最重要的部份、治療計畫理想的時間長度、所需訓練的運動強度、以及治療計畫的效益可維持多久。

譯註

翻譯者:林芷筠
服務單位:嘉義長庚紀念醫院復健科
職稱:研究助理

本翻譯計畫由臺北醫學大學考科藍臺灣研究中心(Cochrane Taiwan)、台灣實證醫學學會及東亞考科藍聯盟(EACA)統籌執行
聯絡E-mail:cochranetaiwan@tmu.edu.tw

எளியமொழிச் சுருக்கம்

நாள்பட்ட நுரையீரல் அடைப்பு நோய்க்கான நுரையீரல் மறுவாழ்வுச் சிகிச்சை

நாள்பட்ட நுரையீரல் அடைப்பு நோய் (க்ரானிக் அப்ஸ்டிரக்டிவ் பல்மொனரி டிசிஸ், சிஓபிடி) என்பது காற்று நுரையீரலுக்கு செல்வதை தடுக்கக் கூடிய ஒரு நாள்பட்ட நுரையீரல் நிலைமையாக வரையறுக்கப்படுகிறது. மூச்சுத்திணறல், இருமல், சோர்வு மற்றும் அடிக்கடி ஏற்படும் மார்பு தொற்று ஆகியவை இதன் அறிகுறிகளுள் அடங்கும். உலகளவில், ஆரோக்கியக் கேட்டிற்கு சிஓபிடி ஒரு முக்கிய காரணமாக உள்ளது.

நுரையீரல் மறுவாழ்வுத் திட்டங்கள் உடற்பயிற்சியை ஒரு முக்கியக் கூறாக ​ உட்கொண்டிருக்கிறது​; சில திட்டங்கள், மதிப்பீடு, கல்வி, உளவியல் ஆதரவு மற்றும் உணவுமுறை ஆலோசனை ஆகிய பிற தலையீடுகளைக் கொண்டிருக்கின்றன. சிஓபிடி சிகிச்சைக்காக பரிந்துரைக்கப்பட்ட அணுகுமுறைகளில் நுரையீரல் மறுவாழ்வுச் சிகிச்சை முக்கியமான ஒன்றாகும். இந்த திறனாய்வு, சிஓபிடி கொண்ட மக்களின் ஆரோக்கியம் தொடர்புடைய வாழ்க்கைத் தரத்தின் மேல் நுரையீரல் மறுவாழ்வுச் சிகிச்சையின் தாக்கத்தை வழக்கமான பராமரிப்பிற்கு எதிராக ஒப்பிட்டது. நாங்கள், 3822 பங்கேற்பாளர்கள் சம்பந்தப்பட்ட 65 ஆய்வுகளை சேர்த்தோம். சீரற்ற சமவாய்ப்பு முறையில், பங்கேற்பாளர்கள் நுரையீரல் மறுவாழ்வுச் சிகிச்சை​​யை ​பெறுவதற்கோ அல்லது வழக்கமான பராமரிப்பை ​பெறுவதற்கோ ஒதுக்கப்பட்டனர். ஆய்வுகளின் தரம் பொதுவாக நன்றாக இருந்தது.

நுரையீரல் மறுவாழ்வுச் சிகிச்சை சிஓபிடி கொண்ட மக்களின் ஆரோக்கியம்-தொடர்புடைய வாழ்க்கைத் தரத்தை மேம்படுத்தியது என்று இந்த திறனாய்வு முனைப்பாகக் கூறுகிறது. சிஓபிடி கொண்ட நோயாளிகளில் நுரையீரல் மறுவாழ்வுச் சிகிச்சையை, மேலாண்மை​ மற்றும் சிஓபிடி கொண்ட ​நோயாளிகளுக்கான ​ சிகிச்சையின் ​ பகுதியாக சேர்ப்பதை முடிவுகள் வலுவாக ஆதரிக்கின்றன.

எதிர்கால ஆய்வுகள், திட்டத்தின் சிறந்த காலஅளவு, தேவையான பயிற்சி தீவிரம் மற்றும் எவ்வளவு காலம் திட்டத்தின் நன்மைகள் நீடிக்கும் போன்ற நுரையீரல் மறுவாழ்வுச் சிகிச்சையின் மிக முக்கிய கூறுகளை அடையாளம் காண்பதில் கவனம் செலுத்த வேண்டும்.

மொழிபெயர்ப்பு குறிப்புகள்

மொழி பெயர்ப்பாளர்கள்: சிந்தியா ஸ்வர்ணலதா ஸ்ரீகேசவன், தங்கமணி ராமலிங்கம், ப்ளசிங்டா விஜய், ஸ்ரீகேசவன் சபாபதி.

Laički sažetak

Plućna rehabilitacija u terapiji kronične opstruktivne plućne bolesti

Kronična opstruktivna plućna bolest (KOPB) kronično je plućno stanje u kojem je otežan protok zraka do plućnog parenhima. Simptomi uključuju otežano disanje, kašalj, umor i učestale infekcije u prsištu. KOPB jest jedna od najčešćih bolesti diljem svijeta.

Ključna komponenta programa plućne rehabilitacije je tjelovježba; neki programi uključuju i druge intervencije, poput procjene, edukacije, psihološke potpore i savjetovanja o prehrani. Plućna je rehabilitacija jedan od ključnih preporučenih pristupa u terapiji KOPB-a. Autori ovog Cochrane sustavnog pregleda usporedili su učinak plućne rehabilitacije s učinkom uobičajene njege na zdravstveni aspekt kvalitete života pacijenata koji boluju od KOPB-a. Uključeno je 65 studija s ukupno 3822 sudionika. Sudionici su metodom slučajnog odabira bili raspoređeni u skupine koje su podvrgnute plućnoj rehabilitaciji, odnosno uobičajenoj njezi. Kvaliteta studija je općenito bila dobra.

Ovaj sustavni pregled ističe da plućna rehabilitacija pozitivno utječe na zdravstveni aspekt kvalitete života u osoba s KOPB-om. Rezultati snažno podupiru uključivanje plućne rehabilitacije u terapiju pacijenata s KOPB-om.

Buduće bi se studije trebale fokusirati na utvrđivanje najbitnijih komponenti plućne rehabilitacije, idealnu duljinu trajanja programa, koliki je intenzitet treninga potreban, te koliko dugo traju pozitivni učinci same rehabilitacije.

Bilješke prijevoda

Cochrane Hrvatska
Prevela: Jelena Šimić
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr

Laienverständliche Zusammenfassung

Pulmonale Rehabilitation bei chronisch obstruktiver Lungenerkrankung

Die 'chronisch obstruktive Lungenerkrankung' (COPD) beschreibt eine chronische Lungenerkrankung, bei welcher die Luftzufuhr in die Lungen behindert wird. Zu den Symptomen gehören Kurzatmigkeit, Husten, Müdigkeit und wiederkehrende Atemwegsinfektionen. COPD spielt weltweit eine führende Rolle als Krankheitsursache.

Programme zur pulmonalen Rehabilitation beinhalten körperliches Training als einen wesentlichen Bestandteil; einige Programme beinhalten weitere Maßnahmen wie beispielsweise Befundaufnahme, Schulung, psychologische Unterstützung und Diätberatung. Die pulmonale Rehabilitation ist eine der vorrangig empfohlenen Ansätze in der Behandlung von COPD. Dieser Review vergleicht die Wirkung einer pulmonalen Rehabilitation gegenüber der Standardversorgung (übliche Versorgung) auf die gesundheitsbezogene Lebensqualität von Menschen mit COPD. Wir schlossen 65 Studien mit 3822 Teilnehmern ein. Die Teilnehmer wurden zufällig einer Gruppe mit pulmonaler Rehabilitation oder der Standardversorgung zugeteilt (randomisiert). Die Qualität der Studien war größtenteils gut.

Dieser Review unterstreicht, dass ein Programm zur pulmonalen Rehabilitation die gesundheitsbezogene Lebensqualität von Menschen mit COPD verbessert. Die Ergebnisse befürworten in hohem Maße den Einbezug eines Programms zur pulmonalen Rehabilitation als Teil des Managements und der Behandlung von Patienten mit COPD.

Zukünftige Studien sollten sich auf die Identifizierung der wichtigsten Bestandteile der pulmonalen Rehabilitation, die ideale Dauer eines Programms, die benötigte Intensität des Trainings und die Dauer des Nutzens der Programme konzentrieren.

Anmerkungen zur Übersetzung

M. Schmidt-Haghiri, freigegeben durch Cochrane Deutschland.

Резюме на простом языке

Легочная реабилитация при хронической обструктивной болезни легких

Хроническая обструктивная болезнь легких (ХОБЛ) это хроническое заболевание легких, при котором нарушается поступление воздуха в легкие. Симптомы ХОБЛ включают одышку, кашель, усталость/утомляемость и частые инфекции дыхательных путей. Во всем мире ХОБЛ является одной из основных причин плохого состояния здоровья.

Программы легочной реабилитации включают в себя упражнения в качестве ключевого компонента; некоторые программы включают другие вмешательства, такие как оценка, образование, психологическая поддержка и рекомендации по питанию. Легочная реабилитация является одним из ключевых рекомендуемых подходов в лечении ХОБЛ. В этом обзоре сравнили влияние легочной реабилитации, по сравнению с обычной помощью, на качество жизни, связанное со здоровьем, у людей с ХОБЛ. Мы включили 65 исследований с участием 3822 участников. Участники были рандомизированы [распределены в случайном порядке] в группы для получения легочной реабилитации или обычной помощи. Качество исследований, в целом, было хорошим.

В этом обзоре подчеркивается, что легочная реабилитация улучшает качество жизни, связанное со здоровьем, у людей с ХОБЛ. Результаты решительно поддерживают включение легочной реабилитации в лечение пациентов с ХОБЛ.

Будущие исследования следует сосредоточить на выявлении наиболее важных компонентов легочной реабилитации, идеальной длительности программы реабилитации, интенсивности необходимых тренировок, и на продолжительности полезного эффекта от проведения программы реабилитации.

Заметки по переводу

Перевод: Масалбекова Аида Азизбековна. Редактирование: Юдина Екатерина Викторовна. Координация проекта по переводу на русский язык: Cochrane Russia - Кокрейн Россия (филиал Северного Кокрейновского Центра на базе Казанского федерального университета). По вопросам, связанным с этим переводом, пожалуйста, обращайтесь к нам по адресу: lezign@gmail.com

Resumen en términos sencillos

Rehabilitación pulmonar para la enfermedad pulmonar obstructiva crónica

La enfermedad pulmonar obstructiva crónica (EPOC) describe una afección pulmonar crónica que impide el suministro de aire a los pulmones. Los síntomas incluyen disnea, tos, cansancio e infección torácica frecuente. En todo el mundo, la EPOC es una causa importante de enfermedad.

Los programas de rehabilitación pulmonar incluyen el ejercicio como un componente clave; algunos programas contienen otras intervenciones como la evaluación, la educación, el apoyo psicológico y el asesoramiento dietético. La rehabilitación pulmonar es uno de los enfoques clave recomendados en el tratamiento de la EPOC. Esta revisión comparó la repercusión de la rehabilitación pulmonar versus la atención habitual en la calidad de vida relacionada con la salud de los pacientes con EPOC. Se incluyeron 65 estudios con 3822 participantes. Los participantes se asignaron al azar a recibir rehabilitación pulmonar o atención habitual. La calidad de los estudios fue en general buena.

Esta revisión destaca que la rehabilitación pulmonar mejora la calidad de vida relacionada con la salud de los pacientes con EPOC. Los resultados apoyan firmemente la inclusión de la rehabilitación pulmonar como parte del control y el tratamiento de los pacientes con EPOC.

Los estudios futuros se deben concentrar en la identificación de los componentes más importantes de la rehabilitación pulmonar, la duración ideal del programa, la intensidad de entrenamiento requerida y la duración de los efectos beneficiosos del programa.

Notas de traducción

La traducción y edición de las revisiones Cochrane han sido realizadas bajo la responsabilidad del Centro Cochrane Iberoamericano, gracias a la suscripción efectuada por el Ministerio de Sanidad, Servicios Sociales e Igualdad del Gobierno español. Si detecta algún problema con la traducción, por favor, contacte con Infoglobal Suport, cochrane@infoglobal-suport.com.

Ringkasan bahasa mudah

Rehabilitasi paru-paru untuk penyakit paru-paru obstruktif kronik

Penyakit paru-paru obstruktif kronik (COPD) adalah keadaan paru-paru kronik yang menghalang bekalan udara dari masuk ke paru-paru. Gejala-gejalanya termasuklah sesak nafas, batuk, keletihan dan jangkitan dada yang kerap. Di seluruh dunia, COPD adalah punca utama kesihatan buruk.

Program rehabilitasi paru-paru termasuklah senaman sebagai komponen utama; beberapa program mengandungi intervensi lain seperti penilaian, pendidikan, sokongan psikologi dan nasihat pemakanan. Rehabilitasi paru-paru adalah salah satu pendekatan utama yang disyorkan dalam rawatan COPD. Ulasan ini membandingkan kesan rehabilitasi paru-paru berbanding penjagaan biasa terhadap kualiti hidup yang berkaitan dengan kesihatan orang dengan COPD. Penyelidik memasukkan 65 kajian yang melibatkan 3822 peserta dalam ulasan ini. Para peserta secara rawak diagihkan untuk menerima samada rehabilitasi paru-paru atau penjagaan biasa. Kualiti kajian pada umumnya adalah baik.

Ulasan ini menekankan bahawa rehabilitasi paru-paru meningkatkan kualiti hidup yang berkaitan dengan kesihatan orang dengan COPD. Keputusannya sangat menyokong untuk memasukkan rehabilitasi paru-paru sebagai sebahagian daripada pengurusan dan rawatan pesakit dengan COPD.

Kajian-kajian masa depan harus menumpukan pada mengenal pasti komponen rehabilitasi paru-paru yang paling penting, tempoh program yang unggul, intensiti latihan yang diperlukan dan tempoh manfaat program terakhir.

Catatan terjemahan

Diterjemahkan oleh Wong Chun Hoong (International Medical University). Disunting olehTuan Hairulnizam Tuan Kamauzaman (Universiti Sains Malaysia). Untuk sebarang pertanyaan berkaitan terjemahan ini sila hubungi wong.chunhoong@hotmail.com

概要

慢性阻塞性肺病的肺部康复

慢性阻塞性肺病指因空气供应到肺受阻的一种慢性肺部疾病。症状包括呼吸急促、咳嗽、疲累和经常性胸部感染。慢性阻塞性肺病是世界上主要的疾病之一。

肺功能康复项目包括运动训练这一关键的科目,一些项目包含了其它干预,如评估、教育、心理支持和饮食建议。在慢性阻塞性肺病的治疗中,肺功能康复是非常重要的组成部分。此系统综述对比了肺功能康复和常规治疗对慢性阻塞性肺病人群的健康相关的生活质量的影响。我们纳入了65项研究涉及3822名受试者。受试者随机分到肺功能康复组或常规治疗组。这些研究的质量普遍较好。

此综述明确了肺功能康复可以改善慢性阻塞性肺病人群的健康相关的生活质量。强烈建议将肺功能康复纳入慢性阻塞性肺病人群的管理和治疗体系中。

未来的研究应该注重于理清肺功能康复最重要的部分,康复项目的理想周期,训练所需的强度,以及康复疗效的持续时长。

翻译注解

译者:杜深星(温州医科大学附属东阳医院),审校:李静,北京中医药大学循证医学中心。2018年2月28日

Summary of findings(Explanation)

Summary of findings for the main comparison. Rehabilitation versus usual care for chronic obstructive pulmonary disease
  1. 117 studies reported random sequence generation (1 unclear), 12 reported allocation concealment 2 did not have allocation concealment and it is unclear in 5 studies. 4 studies did not blind assessors, 11 blinded assessors and 4 were unclear as to assessor blinding. 6 studies had attrition bias greater than 20%.
    2Downgraded as there is a high level of heterogeneity within the results. Several factors may impact heterogeneity, including content of the intervention programme, setting of the programme and severity of COPD.
    3Greater than optimal Information size (OIS). 95% confidence interval does not includes "no effect," nor does the confidence limit cross the MID, so no need to downgrade.
    418 studies reported random sequence generation (2 unclear), 10 reported allocation concealment, 2 did not have allocation concealment and it is unclear in 7 studies. 3 studies did not blind assessors, 9 blinded assessors and 7 were unclear as to assessor blinding. 7 studies had attrition bias greater than 20%.
    5All 8 studies reported random sequence generation, 5 reported allocation concealment and it is unclear in 3 studies. 5 studies had blind assessors with 1 not blinded, and 2 were unclear as to assessor blinding. 4 studies had attrition bias greater than 20%.
    634 studies reported random sequence generation, 4 were unclear, 20 reported allocation concealment, 3 did not have allocation concealment and it is unclear in 15 studies. 5 studies did not blind assessors, 19 blinded assessors and 13 were unclear as to assessor blinding. 13 studies had attrition bias greater than 20% and 2 were unclear.
    7Downgraded as bias indicated for 6-minute walk test: Egger: bias = 1.24304 (95% CI = 0.183967 to 2.302131; P value 0.0227). Begg-Mazumdar: Kendall's tau = 0.16074 (P value 0.1601).
    8All 16 studies reported random sequence generation, 6 reported allocation concealment, 3 did not have allocation concealment and it is unclear in 7 studies. 2 studies did not blind assessors, 10 blinded assessors and 4 were unclear as to assessor blinding. 4 studies had attrition bias greater than 20%.
    9Downgraded as bias indicated for cycle ergometer test: Egger: bias = 1.57164 (95% CI = 0.6053 to 2.337984; P value 0.0036). Begg-Mazumdar: Kendall's tau = -0.2666667 (P value 0.139).

Rehabilitation versus usual care for chronic obstructive pulmonary disease
Patient or population: patients with chronic obstructive pulmonary disease
Settings: hospital and community
Intervention: rehabilitation versus usual care
OutcomesIllustrative comparative effects* (95% CI)Number of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Response on controlTreatment effect
Usual care Rehabilitation versus usual care

QoL - Change in CRQ (dyspnoea)
CRQ Questionnaire. Scale from 1 to 7

(Higher is better and 0.5 unit is an important difference)
Follow-up: median 12 weeks

Median change = 0 unitsMean QoL - change in CRQ (Dyspnoea) in the intervention groups was
0.79 units higher
(0.56 to 1.03 higher)
1283
(19 studies)
⊕⊕⊕⊝
Moderate 1,2,3
Sensitivity analysis from studies at lower risk of bias was similar (MD 0.99, 95% CI 0.64 to 1.34; participants = 384; studies = 5; I2 = 34%)

QoL - Change in SGRQ (total)
Scale from 0 to 100

(Lower is better and 4 units is an important difference)
Follow-up: median 12 weeks

Median change = 0.42 unitsMean QOL - change in SGRQ (total) in the intervention groups was
6.89 units lower
(9.26 to 4.52 lower)
1146
(19 studies)
⊕⊕⊕⊝
Moderate 2,3,4
Sensitivity analysis from studies at lower risk of bias was similar (MD -5.15, 95% CI -7.95 to -2.36; participants = 572; studies = 7; I2 = 51%)
Change in maximal exercise (Incremental Shuttle walk test (ISWT))
Distance metres
Follow-up: median 12 weeks
Median change = 1 metreMean maximal exercise (incremental shuttle walk test) in the intervention groups was
39.77 metres higher
(22.38 to 57.15 higher)
694
(8 studies)
⊕⊕⊕⊝
Moderate 2,3,5
 
Change in functional exercise capacity (6MWT))
Distance metres
Follow-up: median 12 weeks
Median change = 3.4 metresMean functional exercise capacity (6MWT)) in the intervention groups was
43.93 metres higher
(32.64 to 55.21 higher)
1879
(38 studies)
⊕⊝⊝⊝
Very low 2,3,6,7
 
Change in maximal exercise capacity (cycle ergometer)
Workmax (watt)
Follow-up: median 12 weeks
Median change = -0.05 wattsMean maximal exercise capacity (cycle ergometer) in the intervention groups was
6.77 watts higher
(1.89 to 11.65 higher)
779
(16 studies)
⊕⊕⊝⊝
Low 2,3,8,9
 
*The basis for the response on control is the median control group response across studies.
CI: confidence interval; MD: mean difference.
GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

Description of the condition

Chronic obstructive pulmonary disease (COPD) is a multi-factorial progressive chronic lung disease that causes obstruction in airflow. This obstruction results in persistent and progressive breathlessness, productive coughing, fatigue and recurrent chest infection (GOLD 2014). COPD is also associated with extrapulmonary effects such as muscle wasting, osteopaenia (reduction in protein and mineral content of bone tissue), cardiovascular disease and depression and therefore is now best understood as a systemic disease (Agusti 2003; Agusti 2005). Worldwide, COPD is a major cause of morbidity. It is estimated that 210 million people are living with COPD (Franchi 2009), and it is projected that by the year 2030, COPD will be the third most frequent cause of death globally (WHO 2008). At this time, COPD is an incurable condition that is associated with significant economic costs due to progressive disease severity and frequent hospital admissions and readmissions (GOLD 2014; Guarascio 2013).

Risk factors for COPD are numerous and include genetics, recurrent respiratory infection, low socioeconomic status, exposure to air pollutants, poor nutrition and asthma (Eisner 2010; GOLD 2014). However smoking is recognised as a major cause of COPD, and the more a person smokes, the more likely he or she is to develop this condition (Forey 2011).

COPD is a heterogeneous condition with marked variation in progression between individuals (Casanova 2011; Nishimura 2013). The initial underlying pathology of COPD is confined to the lungs, and a clinical diagnosis is based on presenting symptoms and confirmation of airflow obstruction with a postbronchodilator spirometry forced expiratory volume in one second/forced vital capacity ratio (FEV1/FVC) < 0.70 (GOLD 2014). The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines are usually used to grade the severity of airflow limitations as mild (FEV1 ≥ 80% predicted: GOLD 1), moderate (50% ≤ FEV1 < 80% predicted: GOLD 2), severe (30% ≤ FEV1 50% predicted: GOLD 3) or very severe (FEV1 < 30% predicted: GOLD 4) (GOLD 2014).

The symptoms of COPD make engagement in physical activity unpleasant as the result of air trapping and increased hyperinflation in the lungs, which result in increased breathlessness due to subsequent inefficient breathing (O' Donnell 2007). Increased breathlessness provokes anxiety, which inevitably leads to further breathlessness, exacerbation of COPD symptoms and panic. This causes a vicious circle whereby any activities that involve physical exertion are avoided, causing muscle de-conditioning, which further reduces capacity to engage in physical activity (Bourbeau 2007). Physical inactivity is therefore a key predictor of mortality in people with COPD (Garcia-Aymerich 2006; Spruit 2013; Waschki 2011). Consequently, the joint American Thoracic Society and European Respiratory Society (ATS/ERS) (Spruit 2013) guidelines highlight the importance of exercise in the treatment and management of COPD.

Description of the intervention

Treatment interventions for COPD include smoking cessation, pharmacological and non-pharmacological therapies and, in specific circumstances, supplemental oxygen, ventilatory support, surgical treatment and palliative care (GOLD 2014). However, best evidence and all current international guidelines ratify the central role of pulmonary rehabilitation in the treatment of people with COPD (GOLD 2014; NICE 2010; Nici 2006; Ries 2007; Spruit 2013).

Pulmonary rehabilitation (PR), which was first defined by the American College of Chest Physicians Committee in 1974, is a proactive approach to minimising COPD symptoms, improving health-related quality of life (HRQoL) and increasing physical and emotional involvement in everyday life (GOLD 2014; Nici 2006; Ries 2007). The ATS in conjunction with the ERS has published numerous comprehensive statements on PR, with the most recent update in 2013. In the latest update, pulmonary rehabilitation was defined newly as a "…comprehensive intervention based on a thorough patient assessment followed by patient tailored therapies that include, but are not limited to, exercise training, education, and behaviour change, designed to improve the physical and psychological condition of people with chronic respiratory disease and to promote the long-term adherence to health-enhancing behaviours" (Spruit 2013). This new definition differs from the previous one (2006) in that it focuses on the interdisciplinary and therefore more holistic approach to PR rather than on the previous multi-disciplinary approach; highlights the importance of behaviour change; and places PR firmly within the concept of integrated care (Spruit 2013).

Depending on culture, healthcare systems and resources, the structure, personnel, content and settings of PR programmes may vary (Nici 2006; Spruit 2013). However, individually tailored exercise training is considered the cornerstone of PR (Nici 2006; Ries 2007; Spruit 2013). In particular, strength, low- and high-intensity training, exercise endurance and upper and lower extremity training are recommended (Nici 2006; Ries 2007, Spruit 2013). In addition to exercise, the typical comprehensive PR programme includes patient assessment, education, psychosocial support and nutritional counselling (ATS 1999; GOLD 2014; Spruit 2013). Pulmonary rehabilitation is typically delivered to groups of patients (rather than to individuals), but no evidence suggests the optimal size of the exercise group. However, the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR 2011) recommends a staff-to-participant ratio of 1:4, and the British Thoracic Society (British Thoracic Society 2001) a ratio of 1:8. The setting for PR programmes varies; both community-based (Cambach 1997; Casey 2013; Wijkstra 1994a) and home-based programmes (Maltais 2008; Viera 2010) are available. However, traditionally, most PR programmes have been hospital based (Bourbeau 2010), with participants attending as in-patients or on an out-patient basis.

The optimal duration of programmes, number of sessions offered per week and type of staff required to deliver PR programmes are unclear. Beauchamp 2011 concludes, following a systematic review, that available evidence is insufficient to show the optimal duration of PR programmes for people with COPD. However, a programme duration of at least eight weeks is recommended to attain a substantial effect (Beauchamp 2011). Likewise the number of times per week that programmes are offered differs; typically hospital-based out-patient programmes are offered two or three days per week, and in-patient programmes are offered over five days (Spruit 2013). The optimal number of sessions required remains unclear. However, the 2006 ATS/ERS guidelines specify three sessions per week or a twice-weekly supervised and one unsupervised home session (Nici 2006). Finally, key requirements for staff delivering the programme are that they are clinically competent, having the required skills and knowledge and maintain patient safety (Spruit 2013).

How the intervention might work

Pulmonary rehabilitation seeks to reduce COPD symptoms, reestablish and improve functional ability, enhance participation in everyday life, promote autonomy and improve HRQoL (Spruit 2013). It does this by focusing on the systemic aspects of the disease that are common among patients with COPD (AACVPR 2011). The exercise component of PR increases inspiratory volume and reduces dynamic hyperinflation, both of which reduce dyspnoea when the person is performing tasks (Casaburi 2009). Exercise also increases muscle function, delaying fatigue and resulting in increased exercise tolerance. Meanwhile, the educational component of PR focuses on collaborative self-management and behaviour change (Spruit 2013). It encompasses providing information and knowledge regarding COPD; building skills such as goal setting, problem solving and decision making; and developing action plans that allow individuals to better recognise and manage the disease (Spruit 2013). The behaviour change element focuses on modifying nutritional intake and smoking patterns; adhering to medication and regular exercise; and utilising effective breathing techniques and energy-saving strategies (Spruit 2013).

Why it is important to do this review

Review authors undertook the original version of this Cochrane review in 2001 in response to worldwide endorsement of PR as integral to the management of COPD and lack of clear evidence as to the impact of these programmes on HRQoL and exercise tolerance (Lacasse 2001). The review included 23 randomised controlled trials (RCTs), and review authors concluded that PR (exercise training for a minimum of four weeks with or without education and/or psychological support) resulted in statistically significant improvement in HRQoL and modest improvement in exercise capacity (Lacasse 2001). This review was updated in 2006, included 31 RCTs and again reported statistically significant improvement in HRQoL. However, results for both functional and maximal exercise capacity were below the threshold of clinical significance. Lacasse 2006 concluded that further RCTs comparing PR versus usual care for patients with COPD were not needed. Despite this, a large number of RCTs published since 2006 have endorsed the need for this current update. Furthermore, recent RCTs tend to use disease-specific quality of life indices as primary outcome measures,, combined with more refined maximal and functional exercise capacity measurement tools (Curtis 2003; de Torres 2002; Gross 2004; Jones 2003). Consequently in the current review, we will take a more focused approach to assessment of primary and secondary outcomes. In recent years, wide variation has been noted in the follow-up assessment times utilised within studies, and this may have an impact on study outcomes. Therefore in the current review, we will include only assessments completed up to and within three months of completion of the intervention. Also, risk of bias requirements for Cochrane reviews have been altered since the last update; review authors of this current update will ensure that these new requirements are met. Finally, as a separate systematic review examining the effects of PR following exacerbations of COPD has been undertaken (Puhan 2011(a)), we will exclude from this review studies that commenced within four weeks of an acute exacerbation of COPD.

Objectives

To compare the effects of pulmonary rehabilitation versus usual care on health-related quality of life and functional and maximal exercise capacity in persons with COPD.

Methods

Criteria for considering studies for this review

Types of studies

All RCTs in which participants are randomly assigned at the individual or cluster level and in which researchers compare the effects of PR versus those of usual care.

Types of participants

We included RCTs in which more than 90% of participants had COPD defined as:

  • a clinical diagnosis of COPD; and

  • best recorded forced expiratory volume after one second (FEV1)/forced vital capacity (FVC) (FEV1/FVC) ratio of individual participants < 0.7.

We included RCTs in which:

  • any or all participants were on continuous oxygen.

We excluded RCTs that focused on participants:

  • who were mechanically ventilated; or

  • who had an acute exacerbation within four weeks before commencement of the intervention.

Types of interventions

Pulmonary rehabilitation

Any in-patient, out-patient, community-based or home-based rehabilitation programme of at least four weeks' duration that included exercise therapy with or without any form of education and/or psychological support delivered to patients with exercise limitation attributable to COPD.

We included any exercise therapy that included physical activity considered to be aerobically demanding.

We excluded:

  • interventions in which the physical activity component was considered to be not aerobically demanding (e.g. respiratory muscle training, breathing exercises, Tai Chi, yoga) (the degree of aerobic demand was assessed for each individual intervention by examining the detailed description of the intervention in identified studies); and

  • programmes of less than 4 weeks' duration.

Usual care

For the purpose of this review, usual care was defined as conventional care. We excluded trials in which the control group was given education or any form of additional intervention. Participants in the following situations were considered to be in receipt of usual care.

  • Only verbal advice was given. If the advice was accompanied by additional education provided in any way, for example, by video or by diary, then the study was excluded.

  • Medication was altered or optimised to what was considered best practice at the start of the trial for all participants.

Types of outcome measures

We considered disease-specific HRQoL and/or maximal or functional exercise capacity (up to and including three months after the end of the intervention). We defined 'maximal exercise capacity' as the peak capacity measured by an incremental cycle ergometry test. 'Functional exercise capacity' was defined according to the results of timed walk tests (Holland 2014).

Primary outcomes
Disease-specific health-related quality of life (HRQoL)
  • Chronic Respiratory Disease Questionnaire (CRQ).

  • St. George's Respiratory Questionnaire (SGRQ).

Secondary outcomes
Exercise testing

The classification of exercise testing is divided into functional and maximal exercise groups, which include the following (Holland 2014).

  • Functional exercise capacity assessments.

    • Six-minute walk test/distance (6MWT/6MWD).

    • Incremental shuttle walk test (ISWT).

    • Endurance shuttle walk test (ESWT).

  • Maximal exercise tests.

    • Incremental cycle ergometry.

Search methods for identification of studies

Electronic searches

We have detailed in Appendix 1 the search methods used in the previous version of this review. The previously published version included searches up to July 2004. The search period for this update is July 2004 to March 2014.

For the current update, we identified trials from the Cochrane Airways Group Specialised Register (CAGR), which is maintained by the Trials Search Co-ordinator for the Group. The Register contains trial reports identified through systematic searches of bibliographic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Allied and Complementary Medicine Database (AMED) and PsycINFO, and by handsearching of respiratory journals and meeting abstracts (please see Appendix 2 for further details). We searched all records in the CAGR using the search strategy described in Appendix 3.

We also conducted a search of ClinicalTrials.gov (www.ClinicalTrials.gov) and the World Health Organization (WHO) trials portal (www.who.int/ictrp/en/). We searched all databases from their inception to the present, with no restriction on the language of publication. We completed the latest searches in March 2014.

Searching other resources

We reviewed the reference lists of relevant articles and retrieved any potential additional citations. We contacted the authors of studies included in the meta-analysis and experts in the field of pulmonary rehabilitation to uncover unpublished material. We also included the papers suggested by the study authors contacted.

Data collection and analysis

The methods used in this review were designed in accordance with recommendations provided in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Selection of studies

Two review authors (BMC, DC) independently tested the inclusion criteria and sought clarification on all areas of concern with the wider review team, which included the original author of the review (YL). When the review authors were confident of the clarity of the criteria and their skills, they assessed studies with respect to the identified criteria. The two review authors then independently assessed all citation titles and abstracts. Review authors electronically collated initial decisions with the use of Distiller SR and later with Early Reviewing Software (EROS); they coded each citation as:

  • included to proceed;

  • more information needed before inclusion decision;

  • important article but not to be included in the review; or

  • excluded (Appendix 4; Appendix 5).

Review authors held a meeting after every 100 reviewed citations during which they resolved disagreements by consensus. They used quadratic weighted Kappa statistics to measure agreement between coders (Kramer 1981). When consensus could not be reached, a third review author (DD) adjudicated. Review authors then retrieved full-text papers of all potentially eligible studies. Review authors maintained records on all studies that did not meet the inclusion criteria and provided the rationale for their exclusion.

Data extraction and management

The lead review author (BMC) extracted data from all original papers identified for inclusion in the meta-analysis using a developed data extraction form. The other members of the review group (DC, KM, DD, EM) independently extracted data from an equal share of the same studies. Extracted information included the following.

  • Background characteristics of the research reports.

  • Characteristics of participants in the study.

  • The number and distribution of participants who dropped-out or withdrew from the study.

  • A full description of the pulmonary rehabilitation programmes (setting, components and duration).

  • Health-related quality of life measurement instruments and associated results.

  • Exercise capacity measure outcomes and corresponding results.

The lead review author and co-review authors resolved discrepancies during the data extraction process through discussion; they consulted a third review author when unresolved issues remained. Review authors requested missing data from the authors of the primary studies. They asked these authors to provide additional information by filling in tables similar to the ones used by the review authors during the data extraction process. Two review authors (BMC, EM) entered all data into the Review Manager software (RevMan 2011) and checked them for accuracy.

If a study reported multiple group comparisons (e.g. exercise therapy with inspiratory muscle training compared with exercise therapy alone or with conventional community care), treatment groups considered relevant to PR were combined as if one intervention group,.and this group was compared with the group receiving conventional community care. Studies in which multiple group comparisons included interventions that were not considered relevant to PR such as acupuncture were not combined.

Assessment of risk of bias in included studies

The lead review author (BMC) assessed the risk of bias for all included studies. A second review author (DC, EM or KM) independently assessed the risk of bias for each study. The review authors followed the criteria for assessing risk of bias provided by The Cochrane Collaboration in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) and contained in RevMan (RevMan 2011). We assessed risk of bias according to the following domains (Appendix 6).

  • Random sequence generation.

  • Allocation concealment.

  • Blinding of participants and personnel.

  • Blinding of outcome assessment.

  • Incomplete outcome data.

  • Selective outcome reporting.

  • Other bias.

We considered several important potential sources of bias that have proved to be major determinants of the magnitude of the effect size in clinical trials: unconcealed randomisation, unblinded study personnel, incomplete outcome data and attrition of more than 20% of those randomly assigned. The first of these has been associated with an overestimation of treatment effect by up to 40% (Schulz 1995), and the second may result in differential encouragement during performance testing, with the potential for distortion of the results (up to 30.5 metres in a six-minute walk test) (Guyatt 1984). Schulz 1995 argued that loss to follow-up of 20% or greater should be a matter of concern as it relates to the possibility of bias.

Review authors resolved disagreements by consensus. If details pertaining to randomisation, masking, drop-out and withdrawal were not specified or were unclear in the original trial publication, we contacted the study authors to clarify the issue.

Measures of treatment effect

Continuous data

Different measures of HRQoL and exercise capacity have been reported in the primary studies. Both primary outcomes (HRQoL) and secondary outcomes (exercise capacity) are continuous outcomes. For these continuous variables, we recorded mean change from baseline or mean postintervention values and standard deviation (SD) for each group for outcomes measured using the same metrics. When 95% confidence intervals (CIs) and standard errors (SEs) were reported, we calculated SDs as guided by the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). When SDs were missing from studies and it was not possible to obtain the results from study authors, we used a mean value for the SD of the other studies that reported that outcome. All outcomes were reported independently, so standardised mean differences (SMDs) for outcomes were not required. Mean differences (MDs) with 95% CIs were calculated for each study by using a random-effects model.

Dichotomous data

We did not plan to analyse dichotomous outcomes.

Unit of analysis issues

Cluster-randomised trials

We included cluster-randomised trials in the analysis for the current review alongside individually randomised trials. We made an adjustment to the sample size in these studies for each intervention based on the method described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). This method utilised the intracluster correlation co-efficient (ICC) as calculated from trial results.

Multi-armed trials

We included multi-armed trials in this review. To overcome potential issues due to multiple, correlated comparisons, we analysed multi-armed trials using methods described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). When feasible, we combined multiple comparison groups to create one relevant intervention group and one relevant comparison group.

Dealing with missing data

For included studies, we noted the level of attrition; any study with greater than 20% attrition was considered at high risk of attrition bias. When standard deviations (SDs) of the change were missing from studies, and it was not possible to obtain the result from study authors, we used the mean value for the SD of other included studies that reported that outcome. We excluded from the analysis studies in which only medians and percentiles were available and study authors reported no other means of calculating mean change scores.

Assessment of heterogeneity

We assessed heterogeneity visually through inspection of forest plots, and statistical heterogeneity in each meta-analysis using Tau², I² and Chi² statistics. We regarded heterogeneity as substantial when Tau² was greater than zero and I² was greater than 30% or a low P value (< 0.10) was reported for the Chi² test for heterogeneity.

Assessment of reporting biases

When 10 or more studies were included in the meta-analysis, we investigated reporting biases (such as publication bias) by using funnel plots. When asymmetry was suggested on visual assessment, we undertook exploratory analyses to investigate asymmetry using the test proposed by Egger 1997 (see Table 1).

Table 1. Publication bias: results of Egger and Begg-Mazumdar Kendall's tests
CRQ Fatigue

Bias indicators

Begg-Mazumdar: Kendall's tau = 0.22807; P value 0.1863

Egger: bias = 1.61189 (95% CI = -0.194745 to 3.418525); P value 0.077

CRQ Emotional

Bias indicators

Begg-Mazumdar: Kendall's tau = 0.204678; P value 0.2378

Egger: bias = 0.997332 (95% CI = -0.618039 to 2.612702); P value 0.2101

CRQ Mastery

Bias indicators

Begg-Mazumdar: Kendall's tau = 0.146199; P value 0.4063

Egger: bias = 1.531134 (95% CI = -0.268167 to 3.330434); P value 0.0904

CRQ Dyspnoea

(see Figure 1 for funnel plot)

Bias indicators

Begg-Mazumdar: Kendall's tau = 0.274854; P value 0.1082

Egger: bias = 1.275427 (95% CI = -0.761574 to 3.312427); P value 0.204

SGRQ Total

(see Figure 2 for funnel plot)

Bias indicators

Begg-Mazumdar: Kendall's tau = -0.052632; P value 0.73

Egger: bias = -0.459813 (95% CI = -2.086751 to 1.167125); P value 0.5588

SGRQ Symptoms

Bias indicators

Begg-Mazumdar: Kendall's tau = 0.017544; P value 0.945

Egger: bias = 0.076734 (95% CI = -1.241745 to 1.395213); P value 0.9037

SQRQ Activity

Bias indicators

Begg-Mazumdar: Kendall's tau = -0.052632; P value 0.73

Egger: bias = -0.336937 (95% CI = -2.10096 to 1.427086); P value 0.692

6MWT

Bias indicators

Begg-Mazumdar: Kendall's tau = 0.16074; P value 0.1601

Egger: bias = 1.24304 (95% CI = 0.183967 to 2.302131); P value 0.0227

Incremental Shuttle Walk Test

Bias indicators

Begg-Mazumdar: Kendall's tau = 0.0776906; P value 0.846

Egger: bias = -0.21 2523 (95% CI = -2.7776 to 2.351859); P value 0.846

Cycle Ergometer

Bias indicators

Begg-Mazumdar: Kendall's tau = -0.2666667; P value 0.139
Egger: bias = 1.57164 (95% CI = 0.6053 to 2.337984); P value 0.0036

Figure 1.

Funnel plot of comparison: 1 Rehabilitation versus usual care, outcome: 1.4 QoL - Change in CRQ (Dyspnoea) (see Table 1 for Egger and Begg-Mazumdar: Kendall's test results).

Figure 2.

Funnel plot of comparison: 1 Rehabilitation versus usual care, outcome: 1.5 QoL - Change in SGRQ (Total) (see Table 1 for Egger and Begg-Mazumdar: Kendall's test results).

Data synthesis

Review authors undertook statistical analysis by using Review Manager software (RevMan 2011). Throughout the analysis, we used mean differences (MDs) as determined (to take into account pre-experiment group differences) from the differences between preintervention and postintervention changes in treatment and control groups. We combined MDs according to random-effects analyses (Shadish 1994) and presented the results as average treatment effects with 95% CIs and estimates of Tau² and I². In the case of cross-over trials, we considered only the first study period and excluded from the analysis data obtained during the second study period. We explored heterogeneity through a priori specified subgroup analyses. When possible, for each outcome, we discussed the summary effect estimate in the context of its minimal clinically important difference (MCID). The MCID is defined as the smallest difference in score corresponding to the smallest difference perceived by the average patient that would mandate, in the absence of troublesome side effects and excessive costs, a change in management of a patient's condition (Jaeschke 1989).

Subgroup analysis and investigation of heterogeneity

To explain anticipated heterogeneity among study results, we defined a set of three a priori hypotheses on which sensitivity analyses were to be based. We identified potential sources of heterogeneity in relation to the outcomes of exercise capacity and HRQoL. We then classified these hypotheses into subcategories as follows.

Interventions

The contribution of each of the components of PR programmes to patient improvement in exercise capacity and HRQoL is not known. We hypothesised that the more comprehensive the rehabilitation programme, the larger would be the effect size in improving exercise capacity and HRQoL. We also hypothesised that a difference in intervention effect may be noted between hospital only-based and community/home-based interventions. Therefore, we performed a subgroup analysis of:

  • pulmonary rehabilitation and exercise only interventions versus PR plus a more comprehensive intervention within which education was included; and

  • hospital only-based versus community/home-based programmes.

Methodological quality

We hypothesised that the results of trials would be influenced by their methodological quality. For the purpose of this subgroup analysis, we defined high-quality trials as those at low risk of bias for:

  • allocation concealment; or

  • incomplete outcome data (i.e. loss to follow-up ≥ 20%).

We assessed for subgroup differences by using interaction tests available within RevMan (RevMan 2011). We reported the results of subgroup analyses by quoting the statistic and the P value, and the interaction test by providing the I² value.

Sensitivity analysis

We performed sensitivity analyses on the basis of trial quality by repeating our analysis among only those trials judged to be of 'high quality.' For the purposes of this review, 'high-quality' trials are defined as trials with low risk of bias due to allocation concealment or low risk of bias due to incomplete outcome data. We limited sensitivity analyses to primary outcomes (see Types of outcome measures).

Results

Description of studies

See Characteristics of included studies and Characteristics of excluded studies as well as baseline characteristics (Table 2) and study design (Table 3).

Table 2. Baseline characteristics
  1. na: not available.

Study Rehab sample size MaleFemaleMean age (SD)FEV1 (SD)Control sample sizeMaleFemaleMean age (SD)FEV1 (SD)
Barakat 200835nana63.741.936nana65.943.3
Baumann 201237nana654544nana6347
Behnke 2000a2312364.0 (1)34.1 (7.4)2311468.0 (2.2)37.5 (6.6)
Bendstrup 1997277964 (3)1.02 L/min (0.06)207965 (2)1.04 L/min (0.07)
Booker 198432nana66 (8)0.85 L (0.29)37nana65 (7)0.97 L (0.37)
Borghi-Silva 20092013767 (10)33 (9)1412867(10)35 (11)
Boxall 200523111277.6 (7.6)40.5 (15.9)2315875.8 (8.1)37.7 (15.0)
Busch 198875265 (16)26% (9)76166 (16)27% (11)
Cambach 1997157862 (5)59% (16)86262 (9)60% (23)
Casaburi 20041212069 (10)36% (9)1212068 (9)39% (12)
Casey 20131781176168.8 (10.2)57.6 (14.3)1721066668.4 (10.3)59.7 (13.8)
Cebollero 20122828068 (7)47.8 (5)88069(5)38.7 (5)
Chan 20116961873.6 (7.5)91 (0.39)6758973.6 (7.4)89 (0.39)
Chlumsky 20011312163 (11)43% (21)65165 (13)51% (17)
Clark 199632nana58 (8)1.72 L (0.83)16nana55 (8)1.44 L (0.59)
Cochrane 2006743242nana501832nana
Cockcroft 19811818061 (5)1.53 L (0.70)1616060 (5)1.32 L (0.44)
De Souto Araujo 20122112959

39.2 (11.4)

/43.9 (10.3)

118371.145.1 (12.6)
Deering 201125111467.7 (5.3)77.0 (19)198868.6 (5.5)45.8 (18.3)
Elci 20083933659.67 (8.6)47.73933658.08 (11.45)46.28
Emery 199825151465 (6)1.29 L (0.63)25121367 (7)1.02 L (0.37)
Engström 199926141266 (5)31% (11)24121267 (5)34% (10)
Faager 2004103772 (9)26 (7)103770 (8)28 (6)
Faulkner 201010nananana10nananana
Fernandez 20093029166 (8)33 (10)2020070 (5)38 (12)
Finnerty 200136251170 (8)41% (19)29191068 (10)41% (16)
Gohl 2006176462.5 (7)53.4 (10.7)177253.7 (5.8)63.2 (8.5)
Goldstein 199438211766 (7)35% (15)40172365 (8)35% (12)
Gosselink 20003731660 (9)41% (16)3330363 (7)43% (12)
Gottlieb 20113571574.1 (66–82)64.27 (7.9)2671373.2 (67–88)67.05 (8.8)
Griffiths 200093573768 (8)40% (16)91543768 (8)39% (16)
Gurgun 201330282864.0 (10.8)41.9 (10.8)1615167.8 (6.6)39.3 (9.3)
Güell 199530303064 (7)31% (12)3030066 (6)39% (14)
Güell 19981816268 (8)32% (11)1717066 (8)38% (15)
Hernandez 20002020064 (8)71.1 (18.9)1717063 (7)74.7 (14.7)
Hoff 200764262.8 (1.4)49.9 (4.6)64260.6 (3.0)45.2 (6.0)
Jones 198586264 (6)0.78 L (0.27)61563 (8)0.68 L (0.12)
Karapolat 20072621564.81 (9.4)55.50%1918167.21 (6.72)58%
Lake 199076166.3 (6.8)0.83 L (0.25)74365.7 (3.5)0.97 L (0.29)
Lindsay 20052520569.5 (9.3)0.9 L (0.3)2518769.8 (10.3)0.8 L (0.4)
Liu 201236261061.34 (8.3)61.27 (5.86)3629762.2 (6.34)61.43 (6.17)
McGavin 19771212061 (6)0.97 L (0.33)1212057 (8)1.15 L (0.72)
McNamara 201338181572 (10)60 (10)158770 (9)55 (20)
Mehri 20072011952.1 (10.7)na1871152.17 (11.6)na
Mendes De Oliveira 201056461066.4/71.347.5/ 51.529191070.841.4
Nalbant 20111411373.558.5 (48-65)151326857 (44-66)
O'Shea 200727nana66.9 (7)4927nana68.4 (9.9)52
Ozdemir 20102525060.9 (8.8)54.5 (15.6)2525064.1 (8.9)54.1 (20.2)
Paz-Diaz 2007106467 (5)34 (11)1412262 (7)30 (9)
Petty 2006149806968.8 (9.2)na73403366.8 (9.9)na
Reardon 1994105566 (8)35% (10)105566 (7)33% (15)
Ringbaek 20002412362 (7)50% (17)2161565 (8)44% (14)
Gomez 20066439964.1/64.974 (66.5-81.5)3319463.460.1 (55.6-64.4)
Simpson 1992145973 (5)40% (19)1410470 (6)39% (21)
Singh 200320nanana28 (7.5)20nanana26 (7.1)
Sridhar 200861303169.9 (9.6)42.9 (15.5)61303169.68 (10.4)48.9 (18.69)
Strijbos 19961514161 (6)40% (20)1512363 (5)43% (9)
Theander 200915396635.1 (7.6)151046432.3 (9.5)
Vallet 1994107360 (9)57.2108258 (6)55.7
Van Wetering 2010102723065.9 (8.8)58 (17)97692867.2 (8.9)60 (15)
Vijayan 201016nananana15nananana
Weiner 1992126667 (9)32.8 (3)125761 (9)39.2 (2.8)
Wen 20083231167 (7)/68 (7)46 (10)/50 (14)99066(10)52 (14)
Wijkstra 19942823564 (5)44% (11)1514162 (5)45% (9)
Xie 20032522354 (6)42% (16)2521454 (6)40% (17)
Table 3. Study design
StudyFollow-up

Duration

(weeks)

Setting

Programme

type

Barakat 200814 weeks14OutpatientExercise + other
Baumann 20126 months8CommunityExercise + other
Behnke 2000a3, 6 months24InpatientExercise + other
Bendstrup 199712, 24 weeks12OutpatientExercise
Booker 19843, 6, 12 months9HomeExercise + other
Borghi-Silva 20096 weeks6OutpatientExercise
Boxall 200512 weeks12HomeExercise + other
Busch 198818 weeks18HomeExercise
Cambach 19973 months12CommunityExercise + other
Casaburi 200410 weeks10OutpatientExercise + other
Casey 201312 weeks8CommunityExercise + other
Cebollero 201212 weeks12OutpatientExercise
Chan 20113 months12CommunityExercise
Chlumsky 20018 weeks8OutpatientExercise
Clark 199612 weeks12HomeExercise
Cochrane 20066 weeks, 6 months, 12 months6OutpatientExercise + other
Cockcroft 19812, 6 months6OutpatientExercise
De Souto Araujo 20128 weeks8CommunityExercise
Deering 20118 weeks7OutpatientExercise + other
Elci 20081, 3 months12

Community

/Home

Exercise + other
Emery 199810 weeks10OutpatientExercise + other
Engström 199912 months52

Outpatient

/Home

Exercise + other
Faager 20048 weeks, 6 months8

Inpatient

/Home

Exercise + other
Faulkner 2010week 98CommunityExercise + other
Fernandez 20091 year52HomeExercise + other
Finnerty 200112, 24 weeks6OutpatientExercise + other
Gohl 200612 months52CommunityExercise
Goldstein 199424 weeks8InpatientExercise + other
Gosselink 20006, 18 months24OutpatientExercise
Gottlieb 20116 months7CommunityExercise + other
Griffiths 20001 year6

Outpatients

/Home

Exercise + other
Gomez 20063, 6 months12CommunityExercise + other
Güell 19953, 6, 9, 12, 18, 24 months12

Outpatient

/Home

Exercise
Güell 19988 weeks8OutpatientExercise
Gurgun 20138 weeks, 6 months8OutpatientExercise + other
Hernandez 200012 weeks12HomeExercise
Hoff 20078 weeks8OutpatientExercise
Jones 198510 weeks10HomeExercise
Karapolat 20078, 12 weeks8OutpatientExercise + other
Lake 19908 weeks8OutpatientExercise
Lindsay 20056 weeks, 3 months6CommunityExercise + other
Liu 20126 months24

Inpatient

/Home

Exercise
McGavin 197714 weeks?12HomeExercise
McNamara 20138 weeks8OutpatientExercise
Mehri 20074 weeks4OutpatientExercise
Mendes De Oliveira 201012 weeks12

Outpatient

/Home

Exercise + other
Nalbant 20113, 6 months24Nursing homeExercise + other
O'Shea 20073, 6 months12

Outpatient

/Home

Exercise
Ozdemir 20101 month4OutpatientExercise
Paz-Diaz 20078 weeks8OutpatientExercise
Petty 20068 weeks8HomeExercise + other
Reardon 19946 weeks6OutpatientExercise + other
Ringbaek 20008 weeks8OutpatientExercise + other
Simpson 19928 weeks8OutpatientExercise
Singh 20034 weeks4HomeExercise
Sridhar 20086 months6

Outpatients

/Home

Exercise + other
Strijbos 19963, 6, 12, 18 months12OutpatientExercise + other
Theander 200912 weeks12

Outpatient

/Home

Exercise + other
Vallet 19948 weeks8InpatientExercise
Van Wetering 20104 months12CommunityExercise + other
Vijayan 2010Unclear6UnclearExercise
Weiner 19926 months24OutpatientExercise
Wen 200812 weeks12OutpatientExercise
Wijkstra 199412 weeks12

Outpatient

/Home

Exercise + other
Xie 200312 weeks12HomeExercise

Results of the search

Our search yielded 1284 citations with potential for inclusion (see Figure 3). We excluded 1132 citations during the initial screening of titles and abstracts and assessed 98 studies (152 citations) on the basis of a full-text review. Of these, 51 studies (68 citations) failed to meet the inclusion criteria. A further five studies (eight citations) provided insufficient detail to allow a decision and are still awaiting classification (see Characteristics of studies awaiting classification). Of these, we conducted a teleconference with the author of two studies (Meshcheryakova 2010; Meshcheryakova 2012) and are awaiting additional unpublished information. We were not able to establish contact with the authors of the other three studies (Aksu 2006; D'Amico 2010; Ren 2011). Three studies were ongoing at the time of this review, and results were not yet published; the study authors wished to withhold results until after publication (Chang 2008; Gurgun 2011; Sathyapala 2008) (see Characteristics of ongoing studies). In addition, eight citations were related to five studies that were already included in the previous version of this review. Thus, 34 studies (65 citations) were included for the first time in this review, in addition to the 31 studies (65 citations) already included in the previous version of the review. We have provided details of the literature search for the previous version of the review in Appendix 1.

Figure 3.

Study flow diagram.

Included studies

We included the 31 RCTs from the 2006 version of the Cochrane review (Lacasse 2006). A total of 65 studies (represented by 130 citations) contributed to this meta-analysis, including 34 new studies (Barakat 2008; Baumann 2012; Borghi-Silva 2009; Casey 2013; Cebollero 2012; Chan 2011; Cochrane 2006; De Souto Araujo 2012; Deering 2011; Elci 2008; Faager 2004; Faulkner 2010; Fernandez 2009; Gohl 2006; Gomez 2006; Gottlieb 2011; Gurgun 2013; Hoff 2007; Karapolat 2007; Lindsay 2005; Liu 2012; McNamara 2013; Mehri 2007; Mendes De Oliveira 2010; Nalbant 2011; O'Shea 2007; Ozdemir 2010; Paz-Diaz 2007; Petty 2006; Sridhar 2008; Theander 2009; Van Wetering 2010; Vijayan 2010; Wen 2008), in addition to the 31 studies included in the original review (Behnke 2000a; Bendstrup 1997; Booker 1984; Boxall 2005; Busch 1988; Cambach 1997; Casaburi 2004; Chlumsky 2001; Clark 1996; Cockcroft 1981; Emery 1998; Engström 1999; Finnerty 2001; Goldstein 1994; Gosselink 2000; Griffiths 2000; Güell 1995; Güell 1998; Hernandez 2000; Jones 1985; Lake 1990; McGavin 1977; Reardon 1994; Ringbaek 2000; Simpson 1992; Singh 2003; Strijbos 1996; Vallet 1994; Weiner 1992; Wijkstra 1994; Xie 2003). We provided descriptions of these individual studies in the Characteristics of included studies table.

These studies involved 3822 participants, 2090 of whom were randomly allocated to some form of exercise rehabilitation for a minimum duration of four weeks, and 1732 individuals who were randomly assigned to usual care. For a detailed account of the criteria required for inclusion, see Criteria for considering studies for this review. The sample size in the included studies ranged from 12 participants (Hoff 2007) to 350 participants (Casey 2013) with a median of 45 participants (interquartile range (IQR) 29.5 to 67). We noted a large gender imbalance across all studies, with 69% of participants being male and with 10 studies including no female participants.

Only six studies reported patient-based programmes, three of which were combined with a home-based follow-up component. Thirty-seven studies were hospital out-patient based; eight of these included a home-based element. In all, 21 programmes were community based, 11 of which were entirely home based, and one programme combined community- and home-based components. The venue for the programme run by Vijayan 2010 was unclear from the reports. The duration of the programmes ranged from four weeks (three studies) to one year (three studies). Eight- and 12-week programmes (18 studies of each) were most common. Timelines for assessment of participants followed a pattern identical to that of programme duration.

All but two trials that met the inclusion criteria used a standard parallel-group design. Casey 2013 utilised cluster samples from general practices, whereas Cambach 1997 conducted a cross-over trial. Most studies (48 trials) randomly assigned participants to two groups (i.e. rehabilitation and usual care), and three trials randomly assigned participants to three intervention groups, in addition to the usual care group (Casaburi 2004; Cochrane 2006; Lake 1990). The remaining 14 trials utilised two intervention groups and a usual care group (Cebollero 2012; De Souto Araujo 2012; Deering 2011; Emery 1998; Gomez 2006; Gurgun 2013; Jones 1985; Liu 2012; McNamara 2013; Mendes De Oliveira 2010; Petty 2006; Strijbos 1996; Weiner 1992; Wen 2008)

Excluded studies

We excluded 51 studies from the current update during the full-text screening process.The Characteristics of excluded studies table provides full details of the excluded studies.

Risk of bias in included studies

As a result of the nature of the intervention, it was expected that blinding of participants and of professionals who delivered the interventions was not possible. Consequently, risk of performance bias in all studies was high. Risk of bias for other bias domains varied across included studies, and insufficient detail was provided to inform judgement in several included studies (see Figure 4, Risk of bias summary table, and Figure 5, Risk of bias graph, for an overview).

Figure 4.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Figure 5.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Allocation

We judged 53 included studies as having low risk of bias in random sequence generation. Information was insufficient to permit a decision in relation to 12 trials (Bendstrup 1997; Borghi-Silva 2009; Clark 1996; Faager 2004; Fernandez 2009; Hoff 2007; Lindsay 2005; Mehri 2007; Nalbant 2011; Paz-Diaz 2007; Vijayan 2010; Wen 2008). With regard to allocation concealment, we judged 28 studies as having low risk of bias (Behnke 2000a; Booker 1984; Boxall 2005; Busch 1988; Cambach 1997; Casaburi 2004; Casey 2013; Cebollero 2012; Cochrane 2006; Cockcroft 1981; De Souto Araujo 2012; Emery 1998; Engström 1999; Faulkner 2010; Finnerty 2001; Goldstein 1994; Gomez 2006; Gosselink 2000; Gottlieb 2011; Griffiths 2000; Gurgun 2013; Karapolat 2007; Liu 2012; McNamara 2013; Mendes De Oliveira 2010; O'Shea 2007; Theander 2009; Van Wetering 2010) and four studies as having high risk of bias (Baumann 2012; Güell 1995; Güell 1998; Jones 1985); the remaining 33 studies provided insufficient information to inform judgements.

Blinding

Performance bias

As a result of the nature of the intervention, it was not possible to blind participants or professionals who delivered the interventions. Consequently, we judged all studies as having high risk of performance bias.

Detection bias

Across studies, the level of reporting of whether outcome assessment was blinded was relatively poor. We judged 32 studies as having low risk of detection bias ( Barakat 2008; Booker 1984; Busch 1988; Casaburi 2004; Casey 2013; Cebollero 2012; Chan 2011; Cochrane 2006; De Souto Araujo 2012; Deering 2011; Elci 2008; Emery 1998; Engström 1999; Finnerty 2001; Goldstein 1994; Gomez 2006; Griffiths 2000; Güell 1995; Güell 1998; Hernandez 2000; Jones 1985; Lake 1990; Liu 2012; McNamara 2013; O'Shea 2007; Petty 2006; Reardon 1994; Ringbaek 2000; Simpson 1992; Strijbos 1996; Van Wetering 2010; Weiner 1992). In two of these studies (Engström 1999; Simpson 1992), the primary outcome assessment (quality of life) was blinded but the secondary outcome assessment (exercise capacity) was not. In Lake 1990, the cycle ergometer test was blinded, but the six-minute walk test was not. In Busch 1988, the cycle ergometer test was not blinded and the 12-minute walk test was blinded. Among studies that reported blinding of outcome assessment, nine studies were judged as having high risk of detection bias (Boxall 2005; Cambach 1997; Faulkner 2010; Gosselink 2000; Gottlieb 2011; McGavin 1977; Theander 2009; Vallet 1994; Wijkstra 1994), and the remaining 23 studies provided insufficient information to inform judgements.

Incomplete outcome data

We judged 39 studies as having low risk of attrition bias (Barakat 2008; Borghi-Silva 2009; Boxall 2005; Cambach 1997; Casaburi 2004; Chlumsky 2001; Cockcroft 1981; Emery 1998; Engström 1999; Fernandez 2009; Goldstein 1994; Griffiths 2000; Güell 1995; Güell 1998; Gurgun 2013; Hoff 2007; Karapolat 2007; Lake 1990; Lindsay 2005; Liu 2012; McGavin 1977; McNamara 2013; Mehri 2007; O'Shea 2007; Ozdemir 2010; Paz-Diaz 2007; Petty 2006; Reardon 1994; Ringbaek 2000; Simpson 1992; Singh 2003; Strijbos 1996; Theander 2009; Vallet 1994; Van Wetering 2010; Vijayan 2010; Weiner 1992; Wijkstra 1994; Xie 2003) and 22 as having high risk (Baumann 2012 24% of people dropped out; Behnke 2000a 35%; Bendstrup 1997 24%; Booker 1984 27%; Busch 1988 30%; Casey 2013 24%; Chan 2011 23%, Cochrane 2006 43%; De Souto Araujo 2012 24%; Deering 2011 42%; Faager 2004 30%; Faulkner 2010 30%; Finnerty 2001 43%; Gohl 2006 44%; Gomez 2006 48%; Gosselink 2000 62%; Gottlieb 2011 32%; Hernandez 2000 38%; Jones 1985 26%; Mendes De Oliveira 2010 27%; Nalbant 2011 28%; Wen 2008 24%). Information was insufficient to inform judgements in five studies (Cambach 1997; Cebollero 2012; Clark 1996; Elci 2008; Vijayan 2010).

Selective reporting

We found no trial registration protocol for most studies to check whether all prespecified outcomes were reported in the articles. However, outcomes listed in the methods section of the included studies were reported in the results section, with the exception of four studies that were judged to have high risk of reporting bias (i.e. Ozdemir 2010, whose results for the CRQ are incomplete; Paz-Diaz 2007, who did not provide results for the rehabilitation group for CRQ; Petty 2006, in which results of the six-minute walk test and Short Form (SF)-36 are not presented; and Weiner 1992, in which results of the SGRQ are not available ). In relation to publication bias, we visually reviewed the funnel plots (Figure 3; Figure 1; Figure 2) and followed this by performing the Egger test (Egger 1997) (Table 1). Egger test results showed no significant publication bias across the studies included in the current meta-analysis.

Other potential sources of bias

We found no other source of bias, with the exception of a tendency toward increased proportions of male participants, as was highlighted earlier.

Effects of interventions

See: Summary of findings for the main comparison Rehabilitation versus usual care for chronic obstructive pulmonary disease

Pulmonary rehabilitation versus usual care

For this comparison, we included all participants who were randomly assigned in the included studies and received PR (defined as exercise training for at least four weeks with or without educational and/or psychological support) and those allocated to usual care (see Characteristics of included studies for details). We also undertook subgroup analysis as discussed in the Subgroup analysis and investigation of heterogeneity section. All outcomes results utilised in the analyses were based on baseline assessment measurements and the earliest follow-up assessment up to three months after completion of the intervention.

Primary outcomes
Health-related quality of life

Among the 65 trials that met the inclusion criteria of the meta-analysis, 44 made an attempt to measure HRQoL using eight different strategies. Only three of these strategies - the Transitional Dyspnoea Index (TDI; Mahler 1984), the Chronic Respiratory Disease Questionnaire (CRQ; Guyatt 1987a) and the St. Georges Respiratory Questionnaire (SGRQ; Jones 1992) - have been demonstrated to be valid and responsive. Of these, the CRG and the SGRQ have become the recognised standard of assessment of HRQoL amongst patients with COPD and are reported here. We analysed the CRQ and the SGRQ separately. Not all subscales were fully completed by all participants, so the numbers of participants per outcome and per subscale varied.

Chronic Respiratory Disease Questionnaire (CRQ)

Scores for the CRQ are reported on a 7-point scale. Although 23 studies utilised the CRQ to assess HRQoL, only 19 studies (1291 participants) provided results suitable for analysis.

Participants allocated to rehabilitation programmes had, on average, significantly greater changes in HRQoL CRQ scores across all subscales when compared with participants allocated to control groups (Fatigue: MD 0.68, 95% CI 0.45 to 0.92; 19 trials; 1291 participants; Tau² = 0.15; I² = 64%; Analysis 1.1; Emotional function: MD 0.56, 95% CI 0.34 to 0.78; 19 trials; 1291 participants; Tau² = 0.12; I² = 58%; Analysis 1.2; Mastery: MD 0.71, 95% CI 0.47 to 0.95; 19 trials; 1212 participants; Tau² = 0.16; I² = 63%; Analysis 1.3; Dyspnoea: MD 0.79, 95% CI 0.56 to 1.03; 19 trials; 1283 participants; Tau² = 0.15; I² = 63%; Analysis 1.4).

For each of the CRQ domains (dyspnoea, fatigue, emotional function and mastery), the common effect size exceeded the 'minimal clinically important difference' (MCID) (0.5 points on the 7-point scale) (Jaeschke 1989). The lower limit of the confidence interval around the common treatment effect of the dyspnoea domains (Analysis 1.4) exceeded the MCID, indicating not only statistical significance but also clinical significance in the effect of PR. The lower limits of the remaining domains were slightly below the MCID (Analysis 1.1; Analysis 1.2; Analysis 1.3).

Heterogeneity identified across all domains of the CRQ was substantial, as Tau² was greater than zero, and in all cases, I² was greater than 30% and the P value for the Chi² test was less than 0.10. We undertook subgroup and sensitivity analyses to try to explore heterogeneity; although findings are presented later, they did not explain the high level of heterogeneity.

St. George's Respiratory Questionnaire (SGRQ)

Scores for the SGRQ are reported on a 100-point scale. Twenty trials utilised the SGRQ to assess the HRQoL of participants. Results were available in a usable format from 19 trials (a maximum of 1153 participants) for inclusion in the meta-analysis. Barakat 2008 was not included in the analysis, as clarification regarding the SD of the change is needed from the study authors.

Similar to the CRQ, participants allocated to PR programmes had, on average, significantly greater changes in SGRQ scores across all subscales when compared with participants allocated to control groups (SGRQ total: MD -6.89, 95% CI -9.26 to -4.52; 19 trials; 1146 participants; Tau² = 13.17; I² = 59%; Analysis 1.5; SGRQ symptoms: MD -5.09, 95% CI -7.69 to -2.49; 19 trials; 1153 participants; Tau² = 7.79; I² = 26%; Analysis 1.6; SGRQ impact: MD -7.23, 95% CI -9.91 to -4.55; 19 trials; 1149 participants; Tau² = 17.94; I² = 58%; Analysis 1.7; SGRQ activity: MD -6.08, 95% CI -9.28 to -2.88; 19 trials; 1148 participants; Tau² = 27.01; I² = 64%; Analysis 1.8).

For each of the SGRQ domains (as well as the total SGRQ score), the common effect size exceeded the MCID of four (Jones 1991; Quirk 1991) (Analysis 1.5; Analysis 1.6; Analysis 1.7; Analysis 1.8). All results of the analysis for all domains of the SGRQ were statistically significant. However, the extent of the 95% CI around the pooled treatment effect exceeds the MCID only for the SGRQ total and SGRQ impact domains of the SGRQ, demonstrating unequivocal clinical and statistical significance in these domains.

Heterogeneity in results obtained from the total and all subscales of the SGRQ was substantial, with the exception of the symptoms subscale (Analysis 1.6).

Secondary outcomes
Maximal exercise capacity

A total of 34 trials measured maximal exercise capacity. We limited the meta-analysis to the 16 trials that used the incremental cycle ergometer test.

Investigators in 16 studies (779 participants) used the incremental cycle ergometer test. On average, a statistically significant increase in mean Wmax (W) was reported among participants allocated to PR compared with those allocated to usual care (MD 6.77, 95% CI 1.89 to 11.65; Tau² = 40.97; I² = 74%; Analysis 1.10). The common effect size exceeded the MCID (4 watts) proposed by Puhan 2011(b). The maximal exercise test showed substantial heterogeneity in the results obtained.

Functional exercise capacity

Of the included studies, 43 trials used the six-minute walk test as an outcome. Of these, 38 (1879 participants: 1012 actively treated, 867 controls) presented the results in a format that could be used for the meta-analysis (see Analysis 1.11). Investigators reported a statistically significant increase, on average, in the mean difference in metres walked associated with PR (MD 43.93 m, 95% CI 32.64 to 55.21; Tau² = 713.49; I² = 74%; Analysis 1.11). Both the common effect and the lower limit of its confidence interval exceeded the MCID for the 6WMD of 30 metres, as recommended by Holland 2014, indicating the clinical significance of the effect of PR. .

Eight trials (694 participants) reported data on the incremental shuttle walk test (ISWT). These test results were analysed independently from those of the 6MWT. On average, a statistically significant increase in mean metres walked was noted among participants allocated to PR compared with those allocated to usual care (MD 39.77, 95% CI 22.38 to 57.15; Tau² = 181.56; I² = 32%). This result is slightly below the MCID of 47.5 m (Singh 2008; Singh 2014) to make this a finding of clinical significance.

Similar to previous outcomes on maximal exercise, both the six-minute walk test and the analyses demonstrated substantial heterogeneity.

Several other outcome measures were used to measure functional capacity, but because of the limited numbers of trials providing data for these other outcomes (endurance shuttle walk test: two trials; 12-minute walk test: four trials); four-minute walk test: one trial)), these findings were not included in the meta-analysis.

Subgroup and sensitivity analyses
Rehabilitation versus usual care (subgroup analysis hospital- versus community-based pulmonary rehabilitation)

In total, 39 included studies were considered to have a hospital-based PR intervention delivered on an in-patient or out-patient basis. A total of 25 studies focused on programmes that were delivered in the community at community centres or in individuals' homes. One study had both a community-based and an out-patient-based intervention group, so it was excluded from the subgroup analysis (Mendes De Oliveira 2010).

In the subgroup analysis for the CRQ domain outcomes, the 'community' subgroup included nine studies (Cambach 1997; Casey 2013; Faulkner 2010; Gomez 2006; Hernandez 2000; Lindsay 2005; O'Shea 2007; Singh 2003; Wijkstra 1994) and the 'hospital group' included 10 studies (Behnke 2000a; Cebollero 2012; Goldstein 1994; Gosselink 2000; Griffiths 2000; Güell 1995; Güell 1998; McNamara 2013; Simpson 1992; Sridhar 2008; ). For SGRQ outcomes, the community subgroup included nine studies (Baumann 2012; Boxall 2005; Chan 2011; De Souto Araujo 2012; Elci 2008; Fernandez 2009; Gohl 2006; Gottlieb 2011; Van Wetering 2010) and the hospital subgroup included 10 studies (Chlumsky 2001; Deering 2011; Engström 1999; Finnerty 2001; Griffiths 2000; Gurgun 2013; Karapolat 2007; Paz-Diaz 2007; Ringbaek 2000; Theander 2009).

Evidence suggested a significant difference in treatment effect between subgroups for all domains of the CRQ, with higher mean values, on average, in the PR group in hospital than in the community-based group (Analysis 2.1; Analysis 2.2; Analysis 2.3; Analysis 2.4). No subgroup differences were reported for any of the SGRQ domains (Analysis 2.5; Analysis 2.6; Analysis 2.7; Analysis 2.8).

Rehabilitation versus usual care (subgroup analysis 'exercise only' vs 'exercise plus more comprehensive components')

A total of 31 trials were included in the 'exercise only' subgroup, and 34 trials in the 'exercise plus more comprehensive components' subgroup, of which 10 trials in the 'exercise only' subgroup (Cebollero 2012; Gosselink 2000; Güell 1995; Güell 1998; Hernandez 2000; McNamara 2013; O'Shea 2007; Simpson 1992; Singh 2003; Sridhar 2008), and nine in the more comprehensive subgroup (Behnke 2000a; Cambach 1997; Casey 2013; Faulkner 2010; Goldstein 1994; Gomez 2006; Griffiths 2000; Lindsay 2005; Wijkstra 1994) reported CRQ data.

For the SGRQ, five trials were included in the 'exercise only' subgroup (Chan 2011; Chlumsky 2001; De Souto Araujo 2012; Gohl 2006; Paz-Diaz 2007) and 14 trials in the more comprehensive subgroup (Baumann 2012; Boxall 2005; Deering 2011; Elci 2008; Engström 1999; Fernandez 2009; Finnerty 2001; Gottlieb 2011; Griffiths 2000; Gurgun 2013; Karapolat 2007; Ringbaek 2000; Theander 2009; Van Wetering 2010).

No evidence was found of a significant treatment effect between subgroups for all domains of the CRQ (Analysis 3.1; Analysis 3.2; Analysis 3.3; Analysis 3.4) and the SGRQ (Analysis 3.5; Analysis 3.6; Analysis 3.7; Analysis 3.8).

Please see Table 4 for a summary of results of the subgroup analysis.

Table 4. Summary of subgroup analysis
  1. CRQ: Chronic Respiratory Disease Questionnaire; MD: mean difference; SGRQ: St. George's Respiratory Questionnaire.

Pulmonary rehabilitation versus usual care. Subgroup: community versus hospital-delivered programme
Outcome Subscale Subgroups Heterogeneity MD [95% CI] Test for subgroup differences
CRQFatigueCommunityTau² = 0.10; I² = 52%0.44 [0.14, 0.75]Chi² = 3.98, df = 1 (P value 0.05), I² = 74.9%
HospitalTau² = 0.09; I² = 51%0.86 [0.58, 1.14]
CRQEmotional FunctionCommunityTau² = 0.00; I² = 0%0.21 [0.04, 0.39]Chi² = 12.24, df = 1 (P value 0.0005), I² = 91.8%
HospitalTau² = 0.06; I² = 39%0.77 [0.51, 1.03]
CRQMasteryCommunityTau² = 0.07; I² = 45%0.40 [0.12, 0.67]Chi² = 8.58, df = 1 (P value 0.003), I² = 88.3%
HospitalTau² = 0.05; I² = 31%0.95 [0.70, 1.20]
CRQDyspnoeaCommunityTau² = 0.03; I² = 26%0.58 [0.34, 0.81]Chi² = 4.05, df = 1 (P value 0.04), I² = 75.3%
HospitalTau² = 0.17; I² = 60%0.99 [0.66, 1.32]
SGRQTotalCommunityTau² = 24.00; I² = 73%-8.15 [-12.16, -4.13]Chi² = 0.69, df = 1 (P value 0.41), I² = 0%
HospitalTau² = 6.41; I² = 35%-6.05 [-8.91, -3.20]
SGRQSymptomsCommunityTau² = 6.28; I² = 24%-3.66 [-7.07, -0.24]Chi² = 1.65, df = 1 (P value 0.20), I² = 39.2%
HospitalTau² = 4.96; I² = 15%-6.91 [-10.51, -3.30]
SGRQImpactCommunityTau² = 19.91; I² = 63%-8.17 [-12.00, -4.34]Chi² = 0.46, df = 1 (P value 0.50), I² = 0%
HospitalTau² = 22.39; I² = 58%-6.21 [-10.33, -2.09]
SGRQActivityCommunityTau² = 48.91; I² = 78%-7.82 [-13.37, -2.28]Chi² = 0.93, df = 1 (P value 0.33), I² = 0%
HospitalTau² = 10.45; I² = 36%-4.58 [-8.16, -1.00]
Pulmonary rehabilitation versus usual care. Subgroup: exercise only programme versus exercise plus additional elements in programme
Outcome Subscale Subgroups Heterogeneity MD [95% CI] Test for subgroup differences
CRQFatigueExercise onlyTau² = 0.00; I² = 0%0.73 [0.54, 0.92]Chi² = 0.26, df = 1 (P value 0.61), I² = 0%
Exercise + otherTau² = 0.29; I² = 79%0.61 [0.18, 1.03]
CRQEmotional FunctionExercise onlyTau² = 0.00; I² = 0%0.51 [0.31, 0.71]Chi² = 0.09, df = 1 (P value 0.77), I² = 0%
Exercise + otherTau² = 0.28; I² = 79%0.58 [0.16, 1.00]
CRQMasteryExercise onlyTau² = 0.01; I² = 11%0.66 [0.44, 0.88]Chi² = 0.12, df = 1 (P value 0.73), I² = 0%
Exercise + otherTau² = 0.31; I² = 79%0.74 [0.31, 1.18]
CRQDyspnoeaExercise onlyTau² = 0.06; I² = 31%0.83 [0.56, 1.10]Chi² = 0.13, df = 1 (P value 0.72), I² = 0%
Exercise + otherTau² = 0.25; I² = 77%0.74 [0.35, 1.13]
SGRQTotalExercise onlyTau² = 62.83; I² = 70%-7.87 [-16.72, 0.98] 
Exercise + otherTau² = 10.17; I² = 56%-6.76 [-9.19, -4.34]Chi² = 0.06, df = 1 (P value 0.81), I² = 0%
SGRQSymptomsExercise onlyTau² = 0.00; I² = 0%-7.38 [-12.33, -2.44] 
Exercise + otherTau² = 13.88; I² = 41%-4.38 [-7.62, -1.15]Chi² = 0.99, df = 1 (P value 0.32), I² = 0%
SGRQImpactExercise onlyTau² = 33.34; I² = 63%-6.11 [-12.60, 0.38] 
Exercise + otherTau² = 17.12; I² = 59%-7.61 [-10.64, -4.57]Chi² = 0.17, df = 1 (P value 0.68), I² = 0%
SGRQActivityExercise onlyTau² = 139.67; I² = 78%-9.33 [-21.66, 2.99]Chi² = 0.30, df = 1 (P value 0.59), I² = 0%
Exercise + otherTau² = 18.51; I² = 60%-5.79 [-8.95, -2.64]
Sensitivity analysis

A sensitivity analysis included only studies of high quality (studies for which both allocation concealment and Incomplete outcome data were rated as low risk) (see risk of bias table in Figure 4). Thirteen studies met the criteria for high quality (Boxall 2005; Cambach 1997; Cockcroft 1981; Emery 1998; Engström 1999; Goldstein 1994; Griffiths 2000; Karapolat 2007; Liu 2012; McNamara 2013; O'Shea 2007; Theander 2009; Van Wetering 2010). Effect estimates were consistent with overall summary effect estimates for the two primary outcomes when contributing data were restricted to high-quality studies, with the exception of one domain, for which the confidence interval widened enough to include the possibility of no difference between rehabilitation and control. All domains for both the CRQ and the SGRQ continued to be statistically significant when restricted to studies of high quality, with the exception of the SGRQ symptoms domain, which was no longer statistically significant (MD -4.12, 95% CI -8.42 to 0.21;, seven trials; 572 participants; Tau² = 13.82; I² = 46%).

Neither subgroup analyses nor the sensitivity analysis based on quality had any impact on reducing or explaining high levels of heterogeneity.

Discussion

This review summarised 65 studies involving 3822 participants with chronic obstructive pulmonary disease (COPD), 2090 of whom were randomly allocated to some form of exercise rehabilitation for a minimum duration of four weeks, and 1732 individuals randomly assigned to usual care. This is the second update of this review, which was last updated in 2006 (Lacasse 2006). Pulmonary rehabilitation is now accepted within the scientific community as an essential strategy in the ongoing management of people with COPD (GOLD 2014). Development of objective health-related quality of life (HRQoL) outcome measures (Kirshner 1985) and demonstration of a physiological rationale for exercise training in people with COPD (Casaburi 1991; Maltais 1996) have facilitated this acceptance. Results of the previous version of this meta-analysis strongly supported pulmonary rehabilitation (PR) in the management of COPD, and results of this current update reconfirm these findings.

Three aspects of the meta-analysis warrant comment. First, we examined the short-term effects of PR in COPD, that is, the benefits of rehabilitation found at the completion of a programme. When the original review was undertaken, few investigators were examining the long-term benefits of rehabilitation (Guell 2000; Ries 1995; Troosters 2000; Wijkstra 1995). More recently, focus on this aspect of PR has increased and exploration of strategies to maintain early benefits continues (Brooks 2002; Foglio 2001; Ries 2003). This review does not attempt to examine these issues. Second, we have been conservative in concluding clear benefit only when the 95% confidence interval (CI) representing the smallest treatment effect was still greater than the minimal clinically important difference (MCID). Third, we excluded a number of well-conducted studies that have contributed to our understanding of PR, but in which control participants received interventions beyond what was considered conventional care. An example of this is Ries 1995, which was excluded on the grounds that control participants had been given an educational programme. Similarly, several studies in which an intervention such as inspiratory muscle training, psychosocial support or breathing exercises was compared with exercise training were excluded. Only studies in which usual care was directly compared with exercise rehabilitation were included for analysis.

As the care of patients with COPD is largely concerned with treating symptoms (Pauwels 2001), we believe that HRQoL should be considered as the primary outcome in PR. The present meta-analysis reconfirms the findings of the previous version that PR is effective in relieving dyspnoea and fatigue, and in improving patients' emotional function and control over the disease. The magnitude of the improvement lies beyond the MCID.

In most trials, investigators measured HRQoL by using either the Chronic Respiratory Disease Questionnaire (CRQ) or the St. George's Respiratory Questionnaire (SGRQ). Head-to-head comparisons of these questionnaires have been published (Harper 1997; Rutten-van Mölken 1999). In both studies, analyses of reliability, validity and responsiveness did not clearly favour one instrument above the other. Rutten-van Mölken and colleagues (Rutten-van Mölken 1999) suggested that the choice between the CRQ and the SGRQ should be based on other considerations, such as the required sample size. Only one trial included in the meta-analysis reported results from both the CRQ and the SGRQ (Griffiths 2000), with no clear indication that one questionnaire is more sensitive to change than the other. Therefore, comparisons from this meta-analysis are only indirect. We found wider 95% CIs around the pooled treatment effect from the SGRQ - a situation that may be explained by the smaller number of participants contributing to this analysis.

Pulmonary rehabilitation programmes included in the meta-analysis differed in several aspects, including clinical setting, duration and composition. This we believe is responsible for the substantial heterogeneity observed in the results obtained and is in keeping with a recent study by Spruit 2014 and supported by Rochester 2014, who also identified this as an issue requiring further investigation. For instance, the contributions of educational activities and psychological support to exercise training remain uncertain. This information would be of outmost importance to physicians and allied healthcare professionals who prescribe rehabilitation and to those who allocate the resources. We addressed this issue in a systematic overview of the literature (Lacasse 1997). Since the time this review was published, further evidence from randomised controlled trials (RCTs) has been published to better define the type and intensity of exercise (Bernard 1999), as well as the influence of programme components, including patient education and self-management (Bourbeau 2003), nutritional support (Steiner 2003) and respiratory muscle training (Watson 1997). Sometimes, evidence even took the form of systematic reviews (Ferreira 2012; Lotters 2002; Taylor 2005). Such questions were too specific to be directly addressed in this meta-analysis, which aimed to investigate the overall effect of rehabilitation in COPD (not the effects of its components). Nevertheless, homogeneity among study results suggested that less sophisticated rehabilitation programmes may also be effective in improving HRQoL, although the between-study comparison from which this conclusion follows is relatively weak.

Investigators have identified an increase in exercise tolerance and functional activities such as walking as other relevant outcomes of rehabilitation (Fishman 1994; Pauwels 2001). Our current interpretation of the results of the six-minute walk test (6MWT) analysis differs from that of the previous version of the meta-analysis (Lacasse 2006). In 2006, results of the meta-analysis were compared with an MCID of 54 metres (95% CI 37 to 71 metres; Redelmeier 1997). From this comparison, the clinical significance of results obtained from the 2006 meta-analysis was interpreted as uncertain. Since 2006, several studies have further investigated the issue of the MCID in field walk tests in chronic respiratory disease. Results of these studies have recently been summarised in an important systematic review, which was supported by the European Respiratory and American Thoracic Societies (Holland 2014; Singh 2014). Although variability across studies and methods used to determine the MCID is evident, available evidence suggests that the MCID for the 6MWT lies between 25 and 33 metres (median estimate 30 metres). Results of our meta-analysis (i.e. MD of 43.93 metres with 95% CI between 36.24 and 55.21 metres) indicate the clinical significance of the effects of PR.

When compared with the treatment effects of other important modalities of care for patients with COPD, such as long-acting inhaled therapy or oral theophylline and its new derivatives (Kew 2014 ; Ram 2005), rehabilitation resulted in greater improvement in important domains of HRQoL and functional exercise capacity.

The importance of measures of maximal exercise capacity remains to be defined. An initial test may be useful in assisting with the prescription of an appropriate level of training. Retesting may provide physiological evidence that a training response has occurred and may be useful in adjustment of intensity levels during the programme (Jones 1988). As the results of maximal exercise tests correlate poorly with those of HRQoL measures (Guyatt 1985; Wijkstra 1994a), maximal exercise testing cannot serve as a substitute for such measures when the outcome of a rehabilitation programme is evaluated.

Authors' conclusions

Implications for practice

Results of this meta-analysis strongly support pulmonary rehabilitation, including at least four weeks of exercise training, as part of the spectrum of treatment for patients with COPD. We found clinically and statistically significant improvements in important domains of health-related quality of life, including dyspnoea, fatigue, emotional function and mastery, in addition to the six-minute walk/distance test - a measure of functional exercise.

Pulmonary rehabilitation has long been underused in patients with COPD (Brooks 2007; Puhan 2011(a); Yohannes 2004). With the support of current international statements or clinical practice guidelines targeting respiratory rehabilitation in COPD (Bolton 2013; Nici 2006; Spruit 2013), we hope that the results of this meta-analysis will encourage the implementation of new programmes.

Implications for research

Overall, the conclusions of this meta-analysis are in agreement with those of prior meta-analyses published in 1996 and in 2001 (Lacasse 1996; Lacasse 2001). The addition of 34 RCTs since the 2006 update resulted, as expected, in narrowing of the CIs around the common effects of rehabilitation in the outcomes examined. This update continues to support the strong argument that PR is beneficial in improving HRQoL. It also reiterates the view presented in the 2006 update that additional RCTs comparing PR and conventional care in COPD are no longer warranted. However findings of the subgroup analysis undertaken as part of this update do stimulate new questions in relation to PR. The subgroup analysis finding that identified a difference in treatment effect between hospital-based programmes and community-based programmes suggests that further research should be undertaken to compare these two approaches. Similarly, the fact that the subgroup analysis identified no differences between basic exercise PR programmes and those that provided more complex interventions suggests the need to examine and identify the most essential components of PR programmes for achieving the best patient outcomes. Other factors that remain uncertain include the degree of supervision, the intensity of the training and how long the treatment effect persists. Recent recommendations provided by current guidelines from the ATS or ACSM that at least three weekly sessions are necessary for a treatment effect raise issues that require consideration beyond this current review. These specific issues demand further elucidation through RCTs and further meta-analysis.

Acknowledgements

We acknowledge the authors of the primary studies included in the meta-analysis, who have kindly provided additional data and information regarding their previous work. We acknowledge the contributions of Eric Wong, Roger Goldstein and Gordon Guyatt, who co-authored the initial version of this review. We would also like to thank Elizabeth Stovold (CAG Information Specialist) for conducting electronic literature searches, Emma Jackson for assisting with locating papers and Emma Welsh for providing assistance during the editorial process.

Yves Lacasse acknowledges Merck Frosst Canada, who funded a co-author, Sylvie Martin, to work on a previously published version of the review. At the time, the Cochrane Airways Group did not believe that this funding presented a threat to the validity of the Reviews' findings. Merck Frosst Canada was not otherwise involved in the design or conduct of this meta-analysis. We also acknowledge Nederlands Astma Fonds, Netherlands for funding for an earlier version of this review. No authors received funding for the 2015 update of the review.

John White was the Editor for this review and commented critically on the review.

The methods section of this review is based on a standard template used by the Cochrane Airways Group.

Data and analyses

Download statistical data

Comparison 1. Rehabilitation versus usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 QoL - Change in CRQ (Fatigue)191291Mean Difference (IV, Random, 95% CI)0.68 [0.45, 0.92]
2 QoL - Change in CRQ (Emotional Function)191291Mean Difference (IV, Random, 95% CI)0.56 [0.34, 0.78]
3 QoL - Change in CRQ (Mastery)191212Mean Difference (IV, Random, 95% CI)0.71 [0.47, 0.95]
4 QoL - Change in CRQ (Dyspnoea)191283Mean Difference (IV, Random, 95% CI)0.79 [0.56, 1.03]
5 QoL - Change in SGRQ (Total)191146Mean Difference (IV, Random, 95% CI)-6.89 [-9.26, -4.52]
6 QoL - Change in SGRQ (Symptoms)191153Mean Difference (IV, Random, 95% CI)-5.09 [-7.69, -2.49]
7 QoL - Change in SGRQ (Impacts)191149Mean Difference (IV, Random, 95% CI)-7.23 [-9.91, -4.55]
8 QoL - Change in SGRQ (Activity)191148Mean Difference (IV, Random, 95% CI)-6.08 [-9.28, -2.88]
9 Maximal Exercise (Incremental shuttle walk test)8694Mean Difference (IV, Random, 95% CI)39.77 [22.38, 57.15]
10 Maximal Exercise Capacity (cycle ergometer)16779Mean Difference (IV, Random, 95% CI)6.77 [1.89, 11.65]
11 Functional Exercise Capacity (6MWT))381879Mean Difference (IV, Random, 95% CI)43.93 [32.64, 55.21]
Analysis 1.1.

Comparison 1 Rehabilitation versus usual care, Outcome 1 QoL - Change in CRQ (Fatigue).

Analysis 1.2.

Comparison 1 Rehabilitation versus usual care, Outcome 2 QoL - Change in CRQ (Emotional Function).

Analysis 1.3.

Comparison 1 Rehabilitation versus usual care, Outcome 3 QoL - Change in CRQ (Mastery).

Analysis 1.4.

Comparison 1 Rehabilitation versus usual care, Outcome 4 QoL - Change in CRQ (Dyspnoea).

Analysis 1.5.

Comparison 1 Rehabilitation versus usual care, Outcome 5 QoL - Change in SGRQ (Total).

Analysis 1.6.

Comparison 1 Rehabilitation versus usual care, Outcome 6 QoL - Change in SGRQ (Symptoms).

Analysis 1.7.

Comparison 1 Rehabilitation versus usual care, Outcome 7 QoL - Change in SGRQ (Impacts).

Analysis 1.8.

Comparison 1 Rehabilitation versus usual care, Outcome 8 QoL - Change in SGRQ (Activity).

Analysis 1.9.

Comparison 1 Rehabilitation versus usual care, Outcome 9 Maximal Exercise (Incremental shuttle walk test).

Analysis 1.10.

Comparison 1 Rehabilitation versus usual care, Outcome 10 Maximal Exercise Capacity (cycle ergometer).

Analysis 1.11.

Comparison 1 Rehabilitation versus usual care, Outcome 11 Functional Exercise Capacity (6MWT)).

Comparison 2. Rehabilitation versus usual care (subgroup analysis hospital vs community)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 QoL - Change in CRQ (Fatigue)191291Mean Difference (IV, Random, 95% CI)0.68 [0.45, 0.92]
1.1 QoL - Community CRQ (Fatigue)9648Mean Difference (IV, Random, 95% CI)0.44 [0.14, 0.75]
1.2 QoL - Hospital CRQ (Fatigue)10643Mean Difference (IV, Random, 95% CI)0.86 [0.58, 1.14]
2 QoL - Change in CRQ (Emotional Function)191291Mean Difference (IV, Random, 95% CI)0.56 [0.34, 0.78]
2.1 QoL - Community (Emotional Function)9648Mean Difference (IV, Random, 95% CI)0.21 [0.04, 0.39]
2.2 QoL - Hospital CRQ (Emotional Function)10643Mean Difference (IV, Random, 95% CI)0.77 [0.51, 1.03]
3 QoL - Change in CRQ (Mastery)191212Mean Difference (IV, Random, 95% CI)0.71 [0.47, 0.95]
3.1 QoL - Community CRQ (Mastery)9569Mean Difference (IV, Random, 95% CI)0.40 [0.12, 0.67]
3.2 QoL - Hospital CRQ (Mastery)10643Mean Difference (IV, Random, 95% CI)0.95 [0.70, 1.20]
4 QoL - Change in CRQ (Dyspnoea)191283Mean Difference (IV, Random, 95% CI)0.82 [0.59, 1.05]
4.1 QoL - Community Based CRQ (Dyspnoea)8633Mean Difference (IV, Random, 95% CI)0.58 [0.34, 0.81]
4.2 QoL - Hospital Based CRQ (Dyspnoea)11650Mean Difference (IV, Random, 95% CI)0.99 [0.66, 1.32]
5 QoL - Change in SGRQ (Total)191146Mean Difference (IV, Random, 95% CI)-6.89 [-9.26, -4.52]
5.1 QoL - Community in SGRQ (Total)9643Mean Difference (IV, Random, 95% CI)-8.15 [-12.16, -4.13]
5.2 QoL - Hospital SGRQ (Total)10503Mean Difference (IV, Random, 95% CI)-6.05 [-8.91, -3.20]
6 QoL - Change in SGRQ (Symptoms)191153Mean Difference (IV, Random, 95% CI)-5.09 [-7.69, -2.49]
6.1 QoL - Community SGRQ (Symptoms)9649Mean Difference (IV, Random, 95% CI)-3.66 [-7.07, -0.24]
6.2 QoL - Hospital SGRQ (Symptoms)10504Mean Difference (IV, Random, 95% CI)-6.91 [-10.51, -3.30]
7 QoL - Change in SGRQ (Impacts)191149Mean Difference (IV, Random, 95% CI)-7.23 [-9.91, -4.55]
7.1 QoL - Community SGRQ (Impacts)9646Mean Difference (IV, Random, 95% CI)-8.17 [-10.00, -4.34]
7.2 QoL - Hospital SGRQ (Impacts)10503Mean Difference (IV, Random, 95% CI)-6.21 [-10.33, -2.09]
8 QoL - Change in SGRQ (Activity)191148Mean Difference (IV, Random, 95% CI)-6.08 [-9.28, -2.88]
8.1 QoL - Community SGRQ (Activity)9645Mean Difference (IV, Random, 95% CI)-7.82 [-13.37, -2.28]
8.2 QoL - Hospital SGRQ (Activity)10503Mean Difference (IV, Random, 95% CI)-4.58 [-8.16, 1.00]
Analysis 2.1.

Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 1 QoL - Change in CRQ (Fatigue).

Analysis 2.2.

Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 2 QoL - Change in CRQ (Emotional Function).

Analysis 2.3.

Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 3 QoL - Change in CRQ (Mastery).

Analysis 2.4.

Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 4 QoL - Change in CRQ (Dyspnoea).

Analysis 2.5.

Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 5 QoL - Change in SGRQ (Total).

Analysis 2.6.

Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 6 QoL - Change in SGRQ (Symptoms).

Analysis 2.7.

Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 7 QoL - Change in SGRQ (Impacts).

Analysis 2.8.

Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 8 QoL - Change in SGRQ (Activity).

Comparison 3. Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 QoL - Change in CRQ (Fatigue)191291Mean Difference (IV, Random, 95% CI)0.68 [0.45, 0.92]
1.1 QoL - Exercise Only CRQ (Fatigue)10480Mean Difference (IV, Random, 95% CI)0.73 [0.54, 0.92]
1.2 QoL - Exercise + Other CRQ (Fatigue)9811Mean Difference (IV, Random, 95% CI)0.61 [0.18, 1.03]
2 QoL - Change in CRQ (Emotional Function)191291Mean Difference (IV, Random, 95% CI)0.56 [0.34, 0.78]
2.1 QoL - Exercise Only CRQ (Emotional Function)10480Mean Difference (IV, Random, 95% CI)0.51 [0.31, 0.71]
2.2 QoL - Exercise + Other CRQ (Emotional Function)9811Mean Difference (IV, Random, 95% CI)0.58 [0.16, 1.00]
3 QoL - Change in CRQ (Mastery)191212Mean Difference (IV, Random, 95% CI)0.71 [0.47, 0.95]
3.1 QoL - Exercise Only CRQ (Mastery)10480Mean Difference (IV, Random, 95% CI)0.66 [0.44, 0.88]
3.2 QoL - Exercise + Other CRQ (Mastery)9732Mean Difference (IV, Random, 95% CI)0.74 [0.31, 1.18]
4 QoL - Change in CRQ (Dyspnoea)191283Mean Difference (IV, Random, 95% CI)0.79 [0.56, 1.03]
4.1 QoL - Exercise Only CRQ (Dyspnoea)10474Mean Difference (IV, Random, 95% CI)0.83 [0.56, 1.09]
4.2 QoL - Exercise + Other CRQ (Dyspnoea)9809Mean Difference (IV, Random, 95% CI)0.74 [0.35, 1.13]
5 QoL - Change in SGRQ (Total)191146Mean Difference (IV, Random, 95% CI)-6.89 [-9.26, -4.52]
5.1 QoL Exercise Only SGRQ (Total)5230Mean Difference (IV, Random, 95% CI)-7.87 [-16.72, 0.98]
5.2 QoL Exercise + Other SGRQ (Total)14916Mean Difference (IV, Random, 95% CI)-6.76 [-9.19, -4.34]
6 QoL - Change in SGRQ (Symptoms)191153Mean Difference (IV, Random, 95% CI)-5.09 [-7.69, -2.49]
6.1 QoL - Exercise Only SGRQ (Symptoms)5230Mean Difference (IV, Random, 95% CI)-7.38 [-12.33, -2.44]
6.2 QoL - Exercise + Other SGRQ (Symptoms)14923Mean Difference (IV, Random, 95% CI)-4.38 [-7.62, -1.15]
7 QoL - Change in SGRQ (Impacts)191149Mean Difference (IV, Random, 95% CI)-7.23 [-9.91, -4.55]
7.1 QoL - Exercise Only SGRQ (Impacts)5230Mean Difference (IV, Random, 95% CI)-6.11 [-12.60, 0.38]
7.2 QoL - Exercise + Other SGRQ (Impacts)14919Mean Difference (IV, Random, 95% CI)-7.61 [-10.64, -4.57]
8 QoL - Change in SGRQ (Activity)191148Mean Difference (IV, Random, 95% CI)-6.08 [-9.28, -2.88]
8.1 QoL - Exercise Only SGRQ (Activity)5230Mean Difference (IV, Random, 95% CI)-9.33 [-21.66, 2.99]
8.2 QoL - Exercise + Other SGRQ (Activity)14918Mean Difference (IV, Random, 95% CI)-5.79 [-8.95, -2.64]
Analysis 3.1.

Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 1 QoL - Change in CRQ (Fatigue).

Analysis 3.2.

Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 2 QoL - Change in CRQ (Emotional Function).

Analysis 3.3.

Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 3 QoL - Change in CRQ (Mastery).

Analysis 3.4.

Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 4 QoL - Change in CRQ (Dyspnoea).

Analysis 3.5.

Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 5 QoL - Change in SGRQ (Total).

Analysis 3.6.

Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 6 QoL - Change in SGRQ (Symptoms).

Analysis 3.7.

Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 7 QoL - Change in SGRQ (Impacts).

Analysis 3.8.

Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 8 QoL - Change in SGRQ (Activity).

Comparison 4. Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 QoL - Change in CRQ (Dyspnoea)5384Mean Difference (IV, Random, 95% CI)0.99 [0.64, 1.34]
1.1 QoL - Low Risk CRQ (Dyspnoea)5384Mean Difference (IV, Random, 95% CI)0.99 [0.64, 1.34]
2 QoL - Change in CRQ (Emotional Function)5386Mean Difference (IV, Random, 95% CI)0.60 [0.09, 1.11]
2.1 QoL - Low Risk (Emotional Function)5386Mean Difference (IV, Random, 95% CI)0.60 [0.09, 1.11]
3 QoL - Low Risk CRQ (Fatigue)5386Mean Difference (IV, Random, 95% CI)0.90 [0.41, 1.39]
4 QoL - Low Risk CRQ (Mastery)5386Mean Difference (IV, Random, 95% CI)0.77 [0.28, 1.26]
5 QoL - Low Risk SGRQ (Total)7572Mean Difference (IV, Random, 95% CI)-5.15 [-7.95, -2.36]
6 QoL - Low Risk SGRQ (Symptoms)7572Mean Difference (IV, Random, 95% CI)-4.12 [-8.45, 0.21]
7 QoL - Low Risk SGRQ (Impacts)7572Mean Difference (IV, Random, 95% CI)-5.92 [-10.01, -1.82]
8 QoL - Low Risk SGRQ (Activity)7572Mean Difference (IV, Random, 95% CI)-5.33 [-8.10, -2.57]
Analysis 4.1.

Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 1 QoL - Change in CRQ (Dyspnoea).

Analysis 4.2.

Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 2 QoL - Change in CRQ (Emotional Function).

Analysis 4.3.

Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 3 QoL - Low Risk CRQ (Fatigue).

Analysis 4.4.

Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 4 QoL - Low Risk CRQ (Mastery).

Analysis 4.5.

Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 5 QoL - Low Risk SGRQ (Total).

Analysis 4.6.

Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 6 QoL - Low Risk SGRQ (Symptoms).

Analysis 4.7.

Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 7 QoL - Low Risk SGRQ (Impacts).

Analysis 4.8.

Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 8 QoL - Low Risk SGRQ (Activity).

Appendices

Appendix 1. Archive of previous search methods and results

Search strategy used for review versions published up to 2004

We searched all records in the Cochrane Airways Group Register coded as 'COPD' for original articles published in any language using the following strategy: rehabilitat* or fitness* or exercis* or physical* or train*

In the first version of this review (Lacasse 1996), 522 publications were retrieved from the computerised search. The review authors reduced this list to 68 potentially eligible papers (quadratic weighted Kappa 0.53, 95% CI 0.45 to 0.61) that were assessed in detail. From this study list, 47 were excluded as the result of wrong population studies (n = 4), intervention not meeting the definition of rehabilitation (n = 7), control group not receiving conventional community care (n = 29), trials not randomised (n = 7). Both primary review authors agreed to include 17 papers in the meta-analysis (quadratic Kappa 0.89, 95% CI 0.65 to 1.00). Six of the 14 RCTs included in the original meta-analysis (Lacasse 1996) were not uncovered by this literature search. Therefore, a total of 23 randomised controlled trials were included. This represents an addition of nine RCTs to the meta-analysis published in 1996 (Lacasse 1996). We contacted the authors of these trials for any additional information required; response rate was 91% (21/23).

An updated search for the review was undertaken in October 2004, which identified an additional 998 references. These were filtered to a list of 139 references, which were considered in the update of the review. Of these, 93 studies failed to meet the inclusion criteria. The original version of the review as previously indicated had included 23 trials. From the updated search (2004), eight additional RCTs (represented by 17 references) met the inclusion criteria of the review (Behnke 2000a; Boxall 2005; Casaburi 2004; Chlumsky 2001; Finnerty 2001; Güell 1998; Singh 2003; Xie 2003). Six papers were awaiting assessment (Corrado 1995: published as conference abstract; Fernández 1998: paper not available; Shu 1998: published as conference abstract; Tregonning 2000: published as conference abstract; Ward 1999: published as conference abstract; Wright 2002: unclear study methods). One trial was ongoing (Whiteford 2004). As an outcome of the update in 2004, a total of 31 RCTs (represented by 65 references) contributed to the meta-analysis.

Appendix 2. Sources and search methods for the Cochrane Airways Group Specialised Register (CAGR)

Electronic searches: core databases

Database Frequency of search
CENTRALMonthly
MEDLINE (Ovid)Weekly
EMBASE (Ovid)Weekly
PsycINFO (Ovid)Monthly
CINAHL (EBSCO)Monthly
AMED (EBSCO)Monthly

 

Handsearches: core respiratory conference abstracts

Conference Years searched
American Academy of Allergy, Asthma and Immunology (AAAAI)2001 onwards
American Thoracic Society (ATS)2001 onwards
Asia Pacific Society of Respirology (APSR)2004 onwards
British Thoracic Society Winter Meeting (BTS)2000 onwards
Chest Meeting2003 onwards
European Respiratory Society (ERS)1992, 1994, 2000 onwards
International Primary Care Respiratory Group Congress (IPCRG)2002 onwards
Thoracic Society of Australia and New Zealand (TSANZ)1999 onwards

 

MEDLINE search strategy used to identify trials for the CAGR

COPD search

1. Lung Diseases, Obstructive/

2. exp Pulmonary Disease, Chronic Obstructive/

3. emphysema$.mp.

4. (chronic$ adj3 bronchiti$).mp.

5. (obstruct$ adj3 (pulmonary or lung$ or airway$ or airflow$ or bronch$ or respirat$)).mp.

6. COPD.mp.

7. COAD.mp.

8. COBD.mp.

9. AECB.mp.

10. or/1-9

Filter to identify RCTs

1. exp "clinical trial [publication type]"/

2. (randomised or randomised).ab,ti.

3. placebo.ab,ti.

4. dt.fs.

5. randomly.ab,ti.

6. trial.ab,ti.

7. groups.ab,ti.

8. or/1-7

9. Animals/

10. Humans/

11. 9 not (9 and 10)

12. 8 not 11

The MEDLINE strategy and RCT filter are adapted to identify trials in other electronic databases

Appendix 3. Search strategy to identify relevant trials from the CAGR

#1 MeSH DESCRIPTOR Pulmonary Disease, Chronic Obstructive Explode All

#2 MeSH DESCRIPTOR Bronchitis, Chronic

#3 (obstruct*) near3 (pulmonary or lung* or airway* or airflow* or bronch* or respirat*)

#4 COPD:MISC1

#5 (COPD OR COAD OR COBD):TI,AB,KW

#6 #1 OR #2 OR #3 OR #4 OR #5

#7 MeSH DESCRIPTOR Rehabilitation

#8 MeSH DESCRIPTOR Respiratory Therapy

#9 rehabilitat*

#10 fitness*

#11 exercis*

#12 train*

#13 #7 or #8 or #9 or #10 or #11 or #12

#14 #6 and #13

[Note: in search line #4, MISC1 denotes the field in which the reference has been coded for condition, in this case, COPD]

Appendix 4. Exclusion criteria used to sort and categorise references

Exclusion criteria
Less than 90% of participants have a diagnosis of COPD
Not a programme, or programme does NOT contain any exercise component
Has an exercise component but is NOT aerobically demanding
Programme of less than 4 weeks' duration
Control received more than conventional care
Includes ventilated patients (hospital ventilated)
Within 4 weeks post exacerbation
This citation linked to main study paper already being screened
Duplicate citation (identical to a citation previously included)
The intervention is a medication

Appendix 5. Eligibility classification allocated to studies

Classification Action
ExcludedStudy excluded
Important article but not to be included in reviewStudy excluded
Included but needs translationStudy included and proceeds to next stage
IncludedStudy included and proceeds to next stage
More information needed before inclusion decisionAwaiting additional information before study proceeds

Appendix 6. Risk of bias domains and judgements

Sequence generation (possible selection bias)

A detailed description of the methods used to generate the allocation sequence was developed for each study to facilitate an assessment of whether it should produce comparable groups.

Risk of bias for sequence generation was graded based on the following:

  • low risk (any truly random process, e.g. random number table; computer random number generator);

  • high risk (any non-random process, e.g. odd or even date of birth; hospital or clinic record number); or

  • unclear risk.

Allocation concealment (possible selection bias)

A description of the methods used to conceal the allocation sequence for each study was presented, and this determined whether the intervention allocation might have been anticipated in advance of, or during, recruitment, or changed after assignment.

Risk of bias associated with allocation concealment was graded as follows:

  • low risk (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);

  • high risk (open random allocation; unsealed or non-opaque envelopes, alternation; date of birth); or

  • unclear risk.

Blinding of participants and personnel (possible performance bias)

The nature of the interventions involved in pulmonary rehabilitation would make it highly unlikely or impossible to blind participants or personnel delivering the interventions.

However, it would be possible to blind outcome assessors. Therefore, we assessed the risk of bias for blinding of outcome assessors as:

  • high risk;

  • low risk; or

  • unclear risk.

Blinding of outcome assessment (checking for possible detection bias)

We will describe for each included study the methods used, if any, to blind outcome assessors from knowledge

of which intervention participants received. We will assess the risk of bias for blinding of outcome assessment as:

  • low risk;

  • high risk; or

  • unclear risk.

Incomplete outcome data (possible attrition bias associated with withdrawals, drop-outs, deviations from original protocol)

A description of completeness of data for each outcome at all stages of the study was presented. This included examining attrition and exclusions from the analysis. Each study was examined to identify whether attrition and exclusions were reported (comparing the numbers presented at each stage with the total number of randomised participants). The studies were also examined for rationale and justifications explaining any attrition or exclusions. In instances where enough information could be identified or was obtained from the trial authors, we re-included missing data in the analyses. We assessed the risk of bias for completeness of data as follows:

  • low risk (20% or less missing data);

  • high risk (more than 20% missing data); or

  • unclear risk.

Selective reporting bias

Studies were examined for selective outcome reporting bias by cross-checking that all outcomes identified in the methods section of the results publication were reported in the results section of the trial publication(s).

The risk of bias for selective reporting was graded as follows:

  • high risk (where not all of the study’s prespecified outcomes had been reported; one or more reported primary outcomes were not prespecified; outcomes of interest were reported incompletely and so cannot be used; study failed to include results of a key outcome that would have been expected to have been reported);

  • low risk (where it was clear that all of the study’s prespecified outcomes and all expected outcomes of interest to the review have been reported); or

  • unclear risk.

Other sources of bias (bias due to problems not covered by the items above)

If the review authors believed that any other possible sources of bias were matters of concern, these were recorded.

The level at which studies were seen to be free of other problems that could put them at risk of bias was graded as:

  • low risk;

  • high risk; or

  • unclear risk.

Overall risk of bias

An overall judgement was made in relation to whether studies were at high risk of bias, according to the criteria given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) and identified above. The magnitude of the overall bias, along with the degree to which the bias was likely to have impacted the findings, was assessed for each study using the following grades:

  • low risk;

  • high risk; or

  • unclear risk.

What's new

DateEventDescription
21 April 2015AmendedTypo in CI for functional exercise capacity in results corrected.

History

DateEventDescription
26 March 2014New citation required and conclusions have changed

New author team

Abstract, plain language summary and results redrafted. Inclusion criteria modified and outcomes defined. Methods brought up to date, including use of current Cochrane risk of bias tool. Summary of findings table added

Conclusions strengthened through the addition of 35 new studies, and recommendations for future research modified

Only assessments completed up to and within 3 months of completion of the intervention included in the analysis

Studies that commenced within 4 weeks of an acute exacerbation of COPD excluded, as a separate systematic review examined the effects of pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease (Puhan 2011)

Additional subgroup analysis undertaken

26 March 2014New search has been performedNew literature search run
20 August 2008AmendedConverted to new review format
16 June 2006New citation required and conclusions have changedSubstantive amendments made

Contributions of authors

BMC and DC selected trials.
BMC, DC, EM and KM extracted data.
BMC, DC, EM, DD and KM assessed the methodological quality of trials.
BMC was responsible for handling data in RevMan.
BMC and DD designed the meta-analysis.
BMC and DD completed the clinical interpretation of results.
YL provided support and guidance throughout the update and critically reviewed the final manuscript.

Declarations of interest

The review authors DC, BMC, KM and DD were involved in the PRINCE study conducted by Casey 2013, a cluster-randomised trial that was included in this review. The risk of bias table for this study was therefore completed by two independent review authors, who were not involved in this trial but were experienced in conducting Cochrane systematic reviews. These were the review authors EM and Miriam Brennan, Lecturer at the School of Nursing & Midwifery, NUI Galway.

Differences between protocol and review

In this current update, the following changes were made from the previous version.

  • We made the following changes to the inclusion and exclusion criteria.

    • We excluded randomised controlled trials that focused on participants:

      • who were ventilated; or

      • who had an acute exacerbation within four weeks before commencement of the intervention

    • We excluded interventions for which the physical activity component was considered to not be aerobically demanding (such as respiratory muscle training, breathing exercises, Tai Chi and yoga). The degree of aerobic demand was assessed for each individual intervention by examining the detailed description of the intervention in identified studies. We also excluded programmes of less than four weeks' duration.

  • We clarified what was considered usual care.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Barakat 2008

Methods

Study design: RCT

"Randomization was in blocks of 10, using random numbers" (pg 157)

Participants

Setting: out-patients in France

Inclusion criteria:

  • Participants accepted into the study were known to the respiratory team at the hospital as having long-standing airway disease, classified as COPD

Exclusion criteria:

  • Unstable medical conditions such as congestive cardiac failure, cor pulmonale, malignancy or cerebrovascular accident

  • Individuals with sleep apnoea syndrome

Participant status:

Age, years: RG: 63.7; CG: 65.9

Gender (M/F): 67/13

FEV1 % predicted: RG: 41.9; CG: 43.3

Participants randomly assigned:

Randomised: 80

Analysed

Rehab: 35
Control: 36

Interventions

Pulmonary rehabilitation:

Out-patient-based rehabilitation

ULE, LLE, Edu

Duration: 14-Week programme

Outcomes

Assessed: baseline and 14 weeks

Spirometry, SGRQ, 6MWT, Bode Index

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Randomization was in blocks of 10, using random numbers" (pg 157)
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskThe nature of the intervention made it impossible to blind participants to their allocation
Blinding of outcome assessment (detection bias)
All outcomes
Low risk

"All tests including SGRQ outcome assessment [were] blinded" (pg 150)

"All of these tests were supervised by a blinded observer, who subsequently repeated this assessment before the study and at the end of the study (0 and 14 weeks)" (pg 156)

Incomplete outcome data (attrition bias)
All outcomes
Low riskCommenced: 80; completed: 71; attrition: 11.25%
Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone noted

Baumann 2012

Methods Study design: prospective, randomised, controlled, interventional, multi-centre trial
Participants

Setting: Hamburg metropolitan area, multi-centre trial

Inclusion criteria:

  • Age between 50 and 80 years

  • COPD GOLD stage II-IV

  • Smoking history of > 20 pack-years

  • Pharmacological therapy according to current guidelines

  • Written informed consent

Exclusion criteria:

  • Respiratory insufficiency, defined as PaO2 < 55 mmHg and/or PaCO2 > 50 mmHg breathing room air

  • Manifest cardiac insufficiency

  • Uncontrolled arterial hypertension

  • Active malignant disease

  • Symptomatic coronary heart disease or pathological test results in cycle ergometry

  • Limited physical capabilities

  • Musculoskeletal disorders as the cause

  • Unwillingness to return for follow-up

  • Previous or ongoing participation in exercise training programmes

  • Expected inability to attend at least 75% of sessions

Participant status:

Age, years: RG: 65; CG: 63

Gender (M/F): 47/34

FEV1 % predicted: RG: 45; CG:47

Participants randomly assigned:

Randomised: 100

Analysed

Rehab: 37
Control: 44

Interventions

Pulmonary rehabilitation:

Out-patient (hospital based)

Aerobic exercise, ULE, LLE Edu, peer support

Duration: 8 sessions of 20 minutes and 18 sessions of 60 minutes

Usual care:

Standard care consisted of referral back to the participant’s

pulmonologist following baseline assessments. The control group did not take part in any components of the rehabilitation programme

Outcomes

Assessed: baseline and 6 months

6-Minute walk test (6MWT)

Cycle ergometry

Short Form-12 (SF-12), SGRQ

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Randomisation was performed using a computer-generated list of random numbers to assign participants to either training or standard care" (pg 3)
Allocation concealment (selection bias)High risk"Consecutive patients with COPD according to accepted criteria [5] were recruited" (pg 3)
Blinding of participants and personnel (performance bias)
All outcomes
High risk"Due to the nature of the intervention it was not possible to blind subjects to their allocation (pg 2)
Blinding of outcome assessment (detection bias)
All outcomes
Low riskThose supervising the 6MWT were not blinded, whereas those supervising cycle ergometry were blinded
Incomplete outcome data (attrition bias)
All outcomes
High riskCommenced: 42; completed: 32; attrition: 10 (24%)
Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone noted

Behnke 2000a

Methods Study design: RCT
Participants

Setting: work undertaken in Germany

Inclusion criteria:

  • Severe COPD

  • Following acute episode

Exclusion criteria:

  • Evidence of unstable cardiac disease, cor pulmonale decompensation

  • Other disabling diseases that prevented participation in the exercise programme, such as orthopaedic inabilities or peripheral vascular disease

Participant status:

Age, (years± SD): RG: 64.0 ± 1.9; CG: 68.0 ± 2.2

Gender (M/F): RG: 12/3; CG: 11/4

FEV1 % predicted (± SD): RG: 34.1 ± 7.4; 37.5 ± 6.6

Participants randomly assigned:

In-patient and home-based
Randomised: 46
Analysed
Rehab: 15
Control: 15

Interventions

Pulmonary rehabilitation: acute hospital admission followed by home exercise programme for 6 months

LLE, Edu, Psy
Duration: 24 weeks

Usual care:

Control participants were advised to perform exercise but without special instructions

Outcomes

Assessment: baseline and 3, 6 months

6MWT, CRQ

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation was in blocks of 10, using random numbers (from study authors)
Allocation concealment (selection bias)Low riskRandomisation process: sealed envelopes (from study authors)
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the programme knew the allocation
Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk

Does not provide information on blinding of assessors, other than that main researcher undertook assessments

"the questionnaire was administered as a structured interview, and all interviews were performed by the same investigator (M.B.)" (pg 11867)

Incomplete outcome data (attrition bias)
All outcomes
High riskCommenced :46; completed: 30; attrition:16 (35%)
Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone reported

Bendstrup 1997

Methods Study design: RCT
Participants

Setting: Patients came for out-patient rehabilitation to a hospital in Denmark

Inclusion criteria:

  • Forced expiratory volume in 1 second (FEV1) between 25% and 55% of predicted value for age, gender and height

  • Tiffenau index (FEV1/forced vital capacity (FVC) ratio) < 70%

  • Stable condition for at least 4 weeks

  • No change in exercise status, sputum colour and quantity; no changes in medication

Exclusion criteria:

  • Heart disease (moderate or severe ischaemic heart disease, acute myocardial infarction within 3 months, cardiomyopathy and valvular heart disease)

  • Musculoskeletal disease limiting exercise

  • Intermittent claudication limiting exercise

Participant status:

Age, (years ± SD): RG: 64 ± 3; CG: 65 ± 2

Gender (M/F): RG: 7/9; CG: 7/9

Participants randomly assigned:

Randomised: 42
Analysed
Rehab: 16
Control: 16

Interventions

Pulmonary rehabilitation: out-patient

LLE, ULE, IMT
Duration: 12 weeks

Control:

Stated that care was provided by primary physician

Outcomes

Assessment: baseline and 12 weeks

6MWT, CRQ, activities of daily living, York QLQ

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

No information provided other than this:

"The patients were randomly allocated to either an intervention or a control group"

Allocation concealment (selection bias)Unclear riskInformation not available
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the programme knew the allocation
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information was provided in relation to blinding of those carrying out outcome assessments
Incomplete outcome data (attrition bias)
All outcomes
High riskCommenced: 42; completed: 32; attrition: 10 (24%)
Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone noted

Booker 1984

Methods Study design: RCT
Participants

Setting: home-based UK study in London

Inclusion criteria:

  • Patients with CAL and exercise tolerance limited by breathlessness were accepted into the study

Exclusion criteria:

  • Not provided

Participant status:

Age, (years±SD) : RG: 66± 8; CG: 65 ± 7

Gender: not available

Participants randomly assigned:

Randomised: 69
Analysed
Rehab: 32
Control: 37

Interventions

Pulmonary rehabilitation:

LLE, BE, PD, Edu, Psy
Duration: 9 weeks

Outcomes

Assessment: baseline and 3, 6, 12 months

6MWT, DSSI/SAD, daily activity questionnaire

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation process: coin toss
Allocation concealment (selection bias)Low riskStudy investigators unaware as to order of treatment group assignment
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the programme knew the allocation
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAll assessments were carried out by independent assessors who were unaware of the treatment received by each participant - "double-blind" (pg 258)
Incomplete outcome data (attrition bias)
All outcomes
High riskCommenced: 128; completed: 94 (73%); attrition: 27%
Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone noted

Borghi-Silva 2009

Methods Study design: prospective randomised controlled trial
Participants

Setting: Brazil

Inclusion criteria:

  • Diagnosis of COPD according to criteria set forth by GOLD

  • Compliance with medical management

  • No change in medical management and no decompensation episodes for at least 1 month before study initiation

  • No participation in a regular physical exercise programme for at least 6 months before study initiation

Exclusion criteria:

  • Presence of orthopaedic or neurological conditions that would preclude participation in an exercise programme

  • History of cardiac arrhythmias or potential ECG alterations

  • Past history consistent with heart disease, diabetes mellitus, uncontrolled hypertension or other concomitant respiratory diseases

  • Failure to comply with the research protocol

Participant status:

Age (years): RG: 67 ±10; CG: 67 ± 10

Gender (M/F): RG: 13/7; CG: 12/8

FEV1 % predicted (± SD): RG: 64 ± 16; CG: 64 ± 18

Participants randomly assigned:

Randomised: 40

Analysed:

Rehab: 20
Control: 20

Interventions

Pulmonary rehabilitation:

Out-patient (hospital-based) supervised training programme

Aerobic exercise, ULE, LLE

Duration: 6-week programme

Usual care

Outcomes

Assessed: baseline and 6 weeks

6-Minute walk

ReR intervals

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo information available
Allocation concealment (selection bias)Unclear riskNo information available
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnable to blind because of the nature of the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information available
Incomplete outcome data (attrition bias)
All outcomes
Low riskCommenced: 40; completed: 34; attrition: 6 (15%)
Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasUnclear riskNone noted

Boxall 2005

Methods Study design: RCT
Participants

Setting: home-based PR programme in Australia

Inclusion criteria:

  • Diagnosis of COPD by 1 of 4 hospital respiratory specialists

  • Older than 60 years

  • Dyspnoea on exertion

  • Live locally

  • Free from worsening symptoms of disease over the past 2 weeks

  • Motivated to exercise daily unsupervised

Exclusion criteria:

  • Attending out-patient-based pulmonary rehabilitation

  • Restricted shoulder movement

  • Living in a nursing home

  • Previous lung volume reduction surgery

  • Pain limiting mobility

Participant status:

Gender (M/F): RG: 11/12; CG: 15/8

Age (years±SD): RG: 77.6 ±7.6; CG: 75.8 ±8.1

FEV1 % predicted (± SD): RG: 40.5 ±15.9; CG: 37.7 ±15.0

FEV1/FVC % predicted (± SD): RG: 74.4 ± 21.3; CG: 70.4 ± 19.2

Participants randomly assigned:

Randomised: 60
Analysed:
Rehab: 23
Control: 23

Interventions

Pulmonary rehabilitation: supervised home-based

ULE, LLE, Edu
Duration: 12 weeks

Usual care:

Control phase: Participants received no treatment in addition to usual medical care

Outcomes

Assessed: baseline and 12 weeks

6MWT, SGRQ, dyspnoea

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"computer-generated random numbers that were coded into opaque envelopes by a person independent from the study, they retained the envelopes until initial assessment was completed" (pg 380)
Allocation concealment (selection bias)Low riskStudy investigators unaware as to order of treatment group: "computer-generated random numbers that were coded into opaque envelopes by a person independent from the study, they retained the envelopes until initial assessment was completed" (pg 380)
Blinding of participants and personnel (performance bias)
All outcomes
High risk"Neither assessors nor participants were blinded to group assignment in this study" (pg 380)
Blinding of outcome assessment (detection bias)
All outcomes
High risk

"Neither assessors nor participants were blinded to group assignment in this

study" (pg 380)

Incomplete outcome data (attrition bias)
All outcomes
Low riskCommenced: 60; completed: 46 (76.7%); attrition: 23.3%
Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasHigh risk"Had to live locally might bias the sample selection and be motivated to exercised daily" (pg 379)

Busch 1988

Methods Study design: RCT stratified in a random manner
Participants

Setting: home-based; Saskatchewan, Canada

Inclusion criteria:

  • Severe, irreversible airway obstruction

Exclusion criteria:

  • Without apparent or symptomatic ischaemic heart disease or disablement from medical conditions other than COPD

Participant status:

Age (years ± SD): RG: 65 ±16; CG: 66 ±16

Gender (M/F): RG: 5/2; CG: 6/1

FEV1 (± SD): RG: 26% ± 9; CG: 27% ±11

Participants randomly assigned:

Randomised: 14
Analysed:
Rehab: 6
Control: 6

Interventions

Pulmonary rehabilitation:

LLE, BE
Duration: 18 weeks

Usual care:

Control group visited but did not follow the exercise programme

Outcomes

Assessment: baseline and at 18 weeks

CRQ (dyspnoea only), ICET, multi-step stage test

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskLetter received from study author: used a table of random numbers
Allocation concealment (selection bias)Low riskStudy investigators unaware as to order of treatment group assignment
Blinding of participants and personnel (performance bias)
All outcomes
High riskBoth participants and those delivering the intervention were aware of those allocated to the intervention group
Blinding of outcome assessment (detection bias)
All outcomes
Low risk“The testers did not know whether the patients were assigned to the Exercise Group or the Control Group" (pg 470)
Incomplete outcome data (attrition bias)
All outcomes
High riskCommenced: 20; completed: 14; attrition: 6 (30%)
Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasUnclear risk None noted

Cambach 1997

Methods Study design: RCT
Participants

Setting: 8 community-based local physiotherapy practices in The Netherlands

Inclusion criteria:

  • Evidence of dyspnoea and decreased exercise tolerance as a result of obstructive lung disease

  • Age 18–75 years

  • Ability to travel independently to the physiotherapy practice

  • Medication prescribed by a pulmonary physician; motivation to improve self-care

  • Informed consent

Exclusion criteria:

  • Cardiac complaints or locomotor disabilities

  • Hypercapnia; arterial carbon dioxide tension (PaCO2) > 6.0 kPa (45 mmHg)) and/or hypoxia; arterial oxygen tension (PaO2 < 8.7 kPa (65 mmHg)) during rest and/or maximal bicycle exercise testing

Participant status:

Age, (years± SD): RG: 62 ± 5; CG: 62 ± 9

Gender (M/F): RG: 7/8; CG: 6/2

FEV1 % predicted (± SD): RG: 59% ± 16; CG: 60% ± 23

Participants randomly assigned:

Randomised: 99
Analysed:
Rehab: 15
Control: 8

Interventions

Pulmonary rehabilitation: community based

LLE, ULE, Edu, IMT
Duration: 12 weeks. (3 days a week for 90 minutes)

Usual care: medication management only

Outcomes

Assessment: baseline, 3 months

6MWT, CRQ, ICET

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

"Within each physiotherapy practice, four out of eight patients were randomly allocated to group RC, and four patients to group CR (block randomisation procedure; four closed envelopes for condition RC and four closed envelopes for condition CR)

Baseline assessments were carried out prior to randomisation" (pg 105)

Allocation concealment (selection bias)Low risk

Study investigators unaware as to order of treatment group assignment

"four closed envelopes for condition RC and four closed envelopes for condition CR" (pg 105)

Blinding of participants and personnel (performance bias)
All outcomes
High riskBoth participants and those delivering the intervention were aware of those allocated to the intervention group
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome assessments: not blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo information available
Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone identified

Casaburi 2004

Methods Study design: RCT into 4 groups
Participants

Setting: out-patient, Los Angeles

Inclusion criteria:

  • 55 to 80 years, FEV1 of 60% predicted or less (13) and FEV1 to vital capacity ratio of ≤ 60%

  • Screening serum testosterone was ≤ 400 ng/dL

Exclusion criteria:

  • Significant cardiovascular or orthopaedic impairment

  • Body weight < 75% or > 130% of ideal

  • Symptomatic benign prostatic hyperplasia, prostate cancer history, serum prostate specific antigen > 4 g/L or haemoglobin > 16 g/dL

Participant status:

Age (years± SD): RG: 69 (10); CG: 68 (9)

Gender (M/F):RG: 12/0; CG: 12/0

FEV1 % predicted: RG: 36% (9); CG: 39% (12)

Participants randomly assigned:

Randomised: 26
Analysed:
Rehab: 12
Control: 12

Interventions

Pulmonary rehabilitation: out-patient (hospital)

LLE, nutritional instruction provided
Duration: 10 weeks (3 sessions/wk)

Usual care:

Placebo injections and no training

Outcomes

Assessment: baseline and 10 weeks

Peak work rate

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

"Subjects were randomly assigned to treatment groups based on

randomisation tables; randomisation was stratified for age < or ≥ 67 years and FEV1 < or ≥ 40% predicted" (supplement)

Allocation concealment (selection bias)Low riskStudy investigators unaware as to order of treatment group assignment (from study author)
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, it was not possible to blind participants to their allocation of exercise or to blind those delivering the exercise
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"Investigators and study coordinators were blinded as to whether subjects received testosterone or placebo" (supplement)
Incomplete outcome data (attrition bias)
All outcomes
Low riskCommenced: 53; completed: 47 (88.7%); attrition: 6 (11.3%)
Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone identified

Casey 2013

Methods Study design: 2-Arm, cluster-randomised controlled trial
Participants

Setting: community based, West of Ireland

Inclusion criteria:

  • Postbronchial dilator FEV1/FVC ratio < 70%* unless BMI > 30, in which case FEV1/FVC ratio > 70% is acceptable provided other criteria are fully met and the postbronchial dilator predicted value of FEV1 ≥ 30% and ≤ 80%

Exclusion criteria:

  • Underlying co-morbidities or mental health problems (based on the recorded judgement of practice staff), which are likely to impair their capacity to successfully participate in or assimilate new information as part of the rehabilitation programme, or which may pose a risk to health

Participant status:

Age (years± SD): RG: 68.8 ±10.2; CG: 68.4 ± 10.3

Gender (M/F): RG: 117/61; CG: 106/66

FEV1 % (pred ± SD): RG: 57.6 ±14.3 ; CG: 59.7 ±13.8

Participants randomly assigned:

Randomised: 350 (16 clusters in control and 16 clusters in intervention) (participants: 178 intervention; 172 control)

Analysed:

Rehab: 178
Control: 172

Interventions

Pulmonary rehabilitation: community based, structured, nurse-led and delivered in the primary healthcare setting

Aerobic exercise, ULE, LLE, Edu, phone support, respiratory muscle training

Duration: 8 weeks, 2 hours per week

Usual care: routine GP care

Outcomes

Assessment: baseline and 12 weeks

Incremental shuttle walking test, CRQ, Self-Efficacy for Managing Chronic Disease 6-item scale
EuroQol EQ-5D, utilisation of healthcare service

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Random allocation using computerised random sequence generation" (Casey 2013, pg 3)
Allocation concealment (selection bias)Low risk"Group allocation concealment was achieved by giving responsibility for computerised allocation sequence generation and group allocation to a researcher independent of the research team and blinded to baseline outcome data" (Casey 2013, pg 3)
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, unable to blind participants
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"Research assistants trained in outcome assessment, blinded to group allocation" (Casey 2013, pg 3)
Incomplete outcome data (attrition bias)
All outcomes
High riskCommenced: 350; completed: 277 (79%); attrition: 73 (21%)
Selective reporting (reporting bias)Low riskOutcomes reported matched the protocol
Other biasLow riskNone identified

Cebollero 2012

Methods Study design: RCT; randomisation into 3 groups
Participants

Setting: 2 centres in Spain

Inclusion criteria:

  • Dyspnoea (MMRC grades II-III)

  • Current non-smoker status

  • Age 60-80 years

Exclusion criteria:

  • Never smoked

  • Exacerbation of symptoms in the preceding 3 months

  • Co-existing conditions that might limit exercise tolerance

Participant status:

Age (years): PG: 68 (7); CG: 69 (5)

Gender (M/F): all male

FEV1 % (pred): RG: 47.8 (5); REG: 44.3 (11.9); CG: 38.7 (5)

Participants randomly assigned:

Randomised: 36

Combined resistance and endurance group: 14

Resistance alone group: 14

Control: 8

Did not include anyone who did not finish the intervention

Interventions

Pulmonary rehabilitation: out-patient programme (hospital-based PR); 3 groups: resistance training alone (n = 14); combined resistance and endurance training (n = 14); and control group (n = 8)

Duration: 12 weeks. (twice a week 45-60 minutes)

Usual care

Outcomes

Assessment:

baseline and 12 weeks

CRQ, 6MWT

NotesCombined group of REG/RG used in the analysis
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"For each subject included in the study, a researcher picked closed ticket with a number inside (from 1 to 3). The number corresponded to one of the three study groups" (additional information from study author)
Allocation concealment (selection bias)Low riskAllocation: closed ticket with a number inside (additional information from study author)
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, it is not possible to blind participants
Blinding of outcome assessment (detection bias)
All outcomes
Low riskYes, according to the study authors
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not include anyone who did not finish the intervention; unclear as to attrition
Selective reporting (reporting bias)Low riskProvided summary of all outcomes
Other biasLow risk 

Chan 2011

Methods

Study design: single-blind, randomised controlled trial

Randomly assigned to 1 of 3 groups (TCQ group, exercise, control)

Participants

Setting: 5 general outpatient clinics in Hong Kong

Inclusion criteria:

  • Clinically diagnosed with COPD according to the ATS

Exclusion criteria:

  • Could not walk independently

  • Suffered from severe sensory or cognitive impairment

  • Symptomatic ischaemic heart disease

  • Practiced TCQ within a year prior

Participant status:

Age (years ± SD): RG: 73.6±7.5; CG: 73.6 ±7.4

Gender (M/F): RG: 61/8; CG: 58/9

FEV1 % (pred ± SD ): RG: 91 ±.39; CG: 89 ±.39

Participants randomly assigned:

Randomised: 206 (TCQ 70, exercise 69, control 67)
Analysed: (only exercise group)
Rehab:69
Control: 67

Interventions

Pulmonary rehabilitation: community (primary care setting)

ULE, LLE, respiratory muscle training (Tai chi Qigong + exercise)

Duration: completed 60 minutes twice a week for 3 months

Usual care: instructed to maintain usual activities

Outcomes

Assessment: baseline and 3 months

Spirometry results, 6MWD, SGRQ, multi-dimensional scale of perceived social support (MSPSS)

Secondary outcomes

Number of exacerbations, hospital admissions, Borg scale, SaO2

NotesTCQ group not included in the analysis
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Random allocation was done using a randomizer software" (pg 5)
Allocation concealment (selection bias)Unclear riskNot informed
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, unable to blind participants and those delivering the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"Research assistants (RAs) for data collection were blind to the study in order to minimize researcher bias" (pg 6)
Incomplete outcome data (attrition bias)
All outcomes
High riskCommenced: 206; completed: 158 (76.7%); attrition: 48 (23.3%)
Selective reporting (reporting bias)Low riskAll outcomes were reported between Chan 2010 and Chan 2011 articles and protocol paper
Other biasLow riskNone noted

Chlumsky 2001

Methods Study design: RCT into 2 groups
Participants

Setting: out-patient

Inclusion criteria:

  • Moderate to severe COPD

Exclusion criteria:

Participant status:

Age (years ± SD): RG: 63 ±11 ; CG: 65 ±13

Gender (M/F): RG: 12/1; CG: 5/1

FEV1 % (pred ± SD): RG: 43% ±21; CG: 51% ±17

Participants randomly assigned:

Randomised: 19
Analysed:
Rehab: 13
Control: 6

Interventions

Pulmonary rehabilitation: outpatient hospital

LLE, BE
Duration: 8 weeks (60 minutes a week)

Usual care: conventional care

Outcomes

Assessment: baseline and 8 weeks

ICET, SGRQ, 6MWT

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Randomized using specific PC program taking into consideration severity of bronchial obstruction and aimed at desired ratio 2:1" (letter from study author)
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskBoth participants and those delivering the intervention had to be aware of those who were in the intervention group
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo information provided in relation to attrition, and no indication in results that any participants did not complete the second assessment
Selective reporting (reporting bias)Low risk

No trial registration protocol was found at

http://www.controlled-trials.com/mrct/ or www.who.int/trialsearch

(searched for author names and parts of title of paper or intervention)

Other biasLow risk None noted

Clark 1996

Methods Study design: RCT
Participants

Setting: hospital in Glasgow recruited from a hospital chest clinic; recruited for home-based exercise

Inclusion criteria:

  • COPD as defined by the American Thoracic Society

  • Minimum treatment consisted of inhaled bronchodilator and inhaled steroid; maximum treatment included nebulised bronchodilators and long-term oral steroids

Exclusion criteria:

Participant status:

Age (years± SD): RG: 58 ± 8 ; CG: 55 ± 8

Gender (M/F): N/A

FEV1 ± SD : RG: 1.72 L ± 0.83; CG: 1.44 L ±0.59

Participants randomly assigned:

Randomised: 48
Analysed:
Rehab: 32
Control: 16

Interventions

Pulmonary rehabilitation: home exercise

LLE, ULE
Duration: 12 weeks once a week

Usual care:

Control group asked to continue with their usual daily routine

Outcomes

Assessment: baseline and 12 weeks

ICET, ITT
QoL: not measured

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Information not available

"The 48 patients were randomly allocated into training (n=32) or control (n=16) groups, with a 2:1 training versus control ratio" (pg 2591)

Allocation concealment (selection bias)Unclear riskInformation not available
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants undertaking the exercise had to be aware that they were receiving same
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot mentioned whether assessors were blinded
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo account provided of any attrition after allocation; difficult to interpret from the graphs and tables how many completed
Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone noted

Cochrane 2006

Methods Study design: RCT, randomly assigned to 1 of 4 interventions
Participants

Setting: North Tyneside and South Northumberland from primary and secondary care

Inclusion criteria:

  • Males and females between the ages of 40 and 85 years (inclusive)

  • Diagnosis of COPD (FEV1 < 80% of predicted and FEV1/FVC ratio < 70%)

Exclusion criteria:

  • Uncontrolled angina

  • Unable to mobilise (because of severe COPD or other disability)

  • Had previously attended pulmonary rehabilitation

  • Current exacerbation of COPD (antibiotics and/or steroids in previous 6 weeks)

  • Other co-morbidities or communication difficulties that prevented rehabilitation

Participant status:

Age (years± SD ): 68.9 ± 7.3 across all groups

Gender:

male 113 (44.1%): combined 32, exercise 32, CBSM 31, cont 18

Female 143 (55.9%): combined 42, exercise 35, CBSM 33, cont 32

FEV1 % (pred± SD): 52.4% ± 15.7 across all groups

Participants randomly assigned:

Commenced: 256

Group 1: allocated combined: 74

Group 2: allocated exercise: 67

Group 3: allocated CBMS: 65

Group 4: allocated control: 50

Interventions

Pulmonary rehabilitation: out-patient programme (hospital-based PR)

Aerobic, ULE, LLE, cognitive behavioural self-management

Duration: 6 weeks (twice weekly, sessions lasting 2 hours)

Usual care: This group of participants received no intervention, except standard care

Outcomes

Assessment: baseline and 6 weeks, 6, 12 months

CRQ, Short Form-12 (SF-12), Psychological State Hospital Anxiety and Depression Scale, COPD Self-Efficacy Scale (COPD-SES)

NotesIncomplete results available for analysis of CRQ (reported as medians)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"The random allocation sequence was generated using cards numbered one to four, which were picked at random. Randomisation was stratified according to site and cohort. There were different sequences for each site (Northumberland and North Tyneside) and a new sequence was started for each of the five cohorts" (pg 34)
Allocation concealment (selection bias)Low riskSealed envelopes: "Letters detailing the group the subject had been randomised to and details of the intervention were then placed in envelopes. Only the patient ID number was visible on the outside of the envelopes" (pg 34)
Blinding of participants and personnel (performance bias)
All outcomes
High risk"Study participants and the practitioners running the interventions could not be blinded to which intervention they were receiving" (pg 34)
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"However, both the subjects and the researchers were blinded to the results of previous assessments (they were not allowed to see previous answers to questionnaires for example)" (pg 34)
Incomplete outcome data (attrition bias)
All outcomes
High riskCommenced: 256; completed: 46 (57%); attrition: 43%
Selective reporting (reporting bias)Low riskAppeared to report what had been identified for reporting
Other biasLow riskNone reported

Cockcroft 1981

Methods

Study design: RCT

The first 20 were allocated entirely randomly, and the remaining 19 by a method known as "minimisation," which ensured an even spread of certain variables between groups

Randomisation process: sealed envelopes

Outcome assessments: blinded

Participants

Setting: in-patient graduated exercise

Inclusion criteria:

  • Breathless on exertion but no upper limit (FEV1) for entry into the study

Exclusion criteria:

  • Men over the age of 70 years

  • Other disabling conditions such as severe arthritis

  • Those who required domiciliary oxygen

Participant status:

Age (years ± SD): RG: 61± 5; CG: 60 ± 5

Gender (M/F): RG: 18/0; CG: 16/0

FEV1 ± SD: RG: 1.53 L ±0.70; CG: 1.32 L ± 0.44

Participants randomly assigned:

Randomised: 39
Analysed:
Rehab: 18
Control: 16

Interventions

Pulmonary rehabilitation: out-patient rehabilitation centre

LLE, ULE

Duration: 6 weeks
Usual care: given no special advice to exercise

Outcomes

Assessment: baseline and 2, 4 months

12-Minute WT, ITT
Interviews, POMS, Eysenck

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation process: sealed envelopes (letter from study author)
Allocation concealment (selection bias)Low riskStudy investigators unaware as to order of treatment group assignment (Cochrane Grade A)
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs participants had to undertake exercise, they were aware of the group allocation
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information on blinding
Incomplete outcome data (attrition bias)
All outcomes
Low riskCommenced: 39; 3completed: 4; attrition: 12%
Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasLow riskGender selection: male only

De Souto Araujo 2012

Methods

Study design: RCT; participants were allocated to 3 experimental groups: control group (CG), floor group (FG) and aquatic group (AG)

The randomisation process was conducted by a researcher who was not involved in data collection, through the use of opaque envelopes sealed and numbered consecutively in the ratio 1:1:1 and containing study group assignment

Participants

Setting: Brazil

Inclusion criteria:

  • Diagnosis of moderate to severe COPD

  • Informed consent

  • Clinically stable without periods of exacerbation for at least 8 weeks

  • Non-smokers or ex-smokers for at least 3 months

  • Free of lung infection

  • Medical supervision and authorisation

Exclusion criteria:

  • Presented with exacerbation of the disease

  • Neuromuscular, renal and cardiac disease

  • Uncontrolled hypertension and diabetes mellitus

  • Did not perform functional tests or did not complete the 24 sessions

Participant status:

Age (years): RG: [FG: 56.9; AG: 62.4]; CG: 71.1

Gender (M/F): RG:[ FG: 8/5; AG: 4/4]; CG: 8/3

FEV1 % (pred± SD): RG:[ FG: 39.2 ± 11.4; AG: 43.9 ± 10.3]; CG: 45.1 ± 12.6

Participants randomly assigned:

32 participants were randomly assigned

Analysed:
Floor group (FG): 13

Aquatic group (AG): 8

Control group (CG): 11

Interventions

Pulmonary rehabilitation:

Low-intensity water and floor exercises on COPD

Duration: 8 weeks (3 times: Each session lasted 1 hour and 30 minutes)

Usual care

Outcomes

Assessment:

baseline and 8 weeks

(6MWT), BODE Index, SGRQ

NotesCombined 2 intervention groups for analysis
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskThe randomisation process was conducted by a researcher not involved in data collection (contact with study authors)
Allocation concealment (selection bias)Low riskSealed envelopes (contact with study authors)
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnable to blind participants because of the nature of the condition
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAll evaluations (initial and final) were performed by a single investigator, who did not know to which group participants were allocated
Incomplete outcome data (attrition bias)
All outcomes
High risk

42 participants randomly assigned; losses: 10

Attrition: 24%

Selective reporting (reporting bias)Low riskIt was reported that all said they would
Other biasLow riskNone noted

Deering 2011

Methods

Study design: RCT; randomly assigned to 3 groups: controls, PR and acupuncture and PR

Randomisation occurred with the use of a random numbers table

Participants

Setting: Dublin (identified via referral from the respiratory service)

Inclusion criteria:

  • Diagnosis of COPD based on GOLD

  • Referred by a respiratory consultant·or Outreach Team

  • MRC score of ≥ 3

  • Ability to mobilise independently

  • Motivated to exercise independently

Exclusion criteria:

  • Acute exacerbation within the past 4-6 weeks

  • Evidence of ischaemic heart disease

  • Uncontrolled hypertension

  • Insulin-dependent diabetes mellitus or musculoskeletal/neurological

  • Inability to exercise independently

  • Previous attendance at PR programme

Participant status:

Age (years ± SD ): RG: [PR only 67.7 ± 5.3, PR + Acu 65.1 ±9.7]; CG: 68.6 ± 5.5

Gender (M/F): RG: [PR only 11/14, PR + Acu 8/8]; CG: 12/7

FEV1 % (pred ± SD): RG: [PR only 77.0 ±19 , PR + Acu 80.7 ± 24.2]; CG: 45.8 ± 1 8.3

Smokers, packs per year: RG: [PR only 51, PR + Acu 846.5]; CG: 46.2

Participants randomly assigned:

60 randomised (control 19, PR 25, 19 PR + Acu)

Analysed:

14 control

11 PR

Interventions

Pulmonary rehabilitation: out-patient programme (hospital-based PR)

Aerobic, ULE, LLE, respiratory muscle training, Edu

Duration: 7 weeks, 14 PR sessions

Usual care: no specific intervention

Outcomes

Assessment:

Baseline, end of PR and 3-month follow-up

St. George’s Questionnaire

Incremental shuttle walk test

FEV1, Pi Max

Feree Living Physical Activity, EQ5D

NotesOnly the PR group was reported on in the analysis
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation occurred with use of a random numbers table
Allocation concealment (selection bias)Unclear riskNo information available
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, it is not possible to blind participants or those delivering the programme
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAssessors and the medical team analysing the blood samples were blinded to the treatments received
Incomplete outcome data (attrition bias)
All outcomes
High risk

Commenced: 44 in control and PR groups; assessed: 25

Attrition: 19 (42%)

Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasUnclear riskNone identified

Elci 2008

Methods

Study design: RCT; 2 groups

Participants were randomly allocated to control or experimental groups with the use of number tables. Concealed until after allocation; once allocated, both participants and those delivering the intervention were aware of those in the intervention group

Participants

Setting:

  • Secondary care community hospital, Pulmonary Diseases Department, Turkey

Inclusion criteria:

  • Diagnosis of COPD

  • Absence of reversibility residence

  • Within the Malatya city boundary

Exclusion criteria:

  • Diagnosis of other respiratory disease such as tuberculosis or cancer

  • Inability to understand the pulmonary rehabilitation programme

Participant status:

Age (years ± SD): RG: 59.67 ± 8.6; CG: 58.08 ± 11.45

Gender (M/F): RG: 33/6; CG: 33/6

FEV1 % (pred): RG: 47.7; CG: 46.28

FEV1/FVC (± SD): RG: 55.46 ± 8.79; CG: 55.10 ± 7.17

Smokers %: RG: 33.3; CG: 20.5

Participants randomly assigned:

78 participants with COPD randomised:

Analysed:

39 experimental group

39 control group

Interventions

Pulmonary rehabilitation: combined home/community/out-patient

Duration: 3 months; exercises twice a day for 10 minutes, 5 days

a week, at home under the supervision of a relative
All

participants performed 24 sessions

Aoribic, ULE, LLE, Edu

Usual care: Control group received standard medical care

Outcomes

Assessment: baseline,1 month, 3 months

St. George’s Questionnaire

SF-36, HADS Hospital Anxiety and Depression, 6MWT, MMRC

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Randomly allocated to control or

experimental groups with the use of number tables

Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, participants had to be aware of their allocation
Blinding of outcome assessment (detection bias)
All outcomes
Low risk

However, the nurse was blinded to the results of the SF-36, SGRQ,

HADS and MMRC

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo account of attrition provided
Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasHigh riskGender imbalance noted

Emery 1998

Methods

Study design: RCT (3 groups: exercise, education and stress management (EXESM); education and stress management (control)

Randomisation process: random numbers table

Outcome assessments: blinded

Participants

Setting: out-patient

Inclusion criteria:

  • Stable COPD age > 50 years

  • Airflow obstruction demonstrated on spirometry

  • Clinical symptoms of COPD for longer than 6 months

Exclusion criteria:

  • Significant cardiac disease or other diseases that might affect exercise tolerance or learning skills

  • Acute, reversible airway disease (asthma) without fixed airflow obstruction

  • Significant disabling disease such as tuberculosis, pulmonary

  • Fibrosis or cancer; unstable cardiac disorder during the previous 3 months

  • Medical conditions that limit participation in a regular exercise programme

Participant status:

Age (years ± SD): RG: 65 ± 6; CG: 67 ± 7

Gender (M/F): RG: 15:15; CG: 12/13

FEV1 (±SD): RG: 1.29 L ± 0.63; CG: 1.02 L ± 0.37

Participants randomly assigned:

Randomised: 79
Analysed:
Rehab: 25
Control: 25

Interventions

Pulmonary rehabilitation: 3 groups: floor group (FG), aquatic group (AG) and control group (out-patient)

LLE, ULE, Edu, Psy
Duration: 10 weeks (for 4 hours per day)

Usual care: asked not to alter activities significantly during the 10-week study

Outcomes

Assessment: baseline and after the 10-week intervention period

ICET, SIP

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskFrom a random number schedule, printed on a piece of paper
Allocation concealment (selection bias)Low riskStudy investigators unaware as to order of treatment group assignment (Cochrane Grade A)
Blinding of participants and personnel (performance bias)
All outcomes
High riskConcealed until after allocation; once allocated, both participants and those delivering the intervention were aware of those in the intervention group
Blinding of outcome assessment (detection bias)
All outcomes
Low riskTechnical staff conducting the assessments were not aware of group assignments
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Overall loss: 6

Attrition: 7.6%

Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone noted

Engström 1999

Methods Study design: RCT (2 groups)
Participants

Setting: out-patients and home patients recruited from Pulmonary Medicine Department in Goteborg, Sweden

Inclusion criteria:

  • Diagnosis of COPD

  • Age 47-75 years

  • FEV1 < 50% (pred) after bronchodilator paO2 of 8 kPa and stable condition

Exclusion criteria:

  • Disabling or severe disease other than COPD or the co-existence of other causes of impaired pulmonary function

Participant status:

Age (years ± SD): RG: 66 ± 5; CG: 67 ± 5

Gender (M/F): RG: 14/12; CG: 12/12

FEV1 % (pred): RG: 30.7; CG: 34.1

Smokers: RG: 6; CG: 4

Participants randomly assigned:

Randomised: 55
Analysed:
Rehab: 26
Control: 24

Interventions

Pulmonary rehabilitation: out-patient and home based

LLE, ULE, Edu, IMT
Duration: 52 weeks (training at the physio department twice weekly for 6 weeks followed by once weekly for 6 weeks and every second week for 6 weeks, then monthly for the remainder of the year. Each session lasted 45 minutes

Usual care:

Control received usual out-patient care

Outcomes

Assessment: baseline to 12 months

6-Minute WT, ICET
SIP, SGRQ

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer random number tables
Allocation concealment (selection bias)Low riskStudy investigators unaware as to order of treatment group assignment (Cochrane Grade A)
Blinding of participants and personnel (performance bias)
All outcomes
High riskThose receiving the programme had to be aware that they were receiving the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessments: blinded for HRQoL, not blinded for WT
Incomplete outcome data (attrition bias)
All outcomes
Low risk

50 out of 55 completed (90.9%)

Attrition rate: 9.1%

Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone identified

Faager 2004

Methods Study design: RCT (2 groups); 2 weeks after onset of oxygen therapy, 20 participants were randomly assigned to rehabilitation
Participants

Setting: in-patient/home Department of Pulmonary Medicine of the Karolinska Hospital: over 2 years

Inclusion criteria:

  • Diagnosis of COPD

  • Established need for LTOT

  • Ability to move about with or without a walking frame

  • Willingness to participate in the study

Exclusion criteria:

  • Symptomatic cardiac disease or neurological or orthopaedic mobility impairment

Participant status:

Age (years ± SD): RG: 72 ± 9; CG: 70 ± 8

Gender (M/F): RG: 3/7; CG: 3/7

FEV1 % (pred ± SD): RG: 26 ± 7 ; CG: 28 ± 6

Participants randomly assigned:

Randomised: 20 (RG: 10; CG: 10)
Analysed:
Rehab: 7
Control: 7

Interventions

Pulmonary rehabilitation: in-patient and home based

Aerobic, ULE, LLE, Edu

Duration: 8-Week programme with 1 training session a week; training took 90 to 120 minutes

Usual care

Outcomes

Assessment: baseline and 8 weeks, 6 months

CRQ, 6-Minute WT, spirometry, blood gas analyses, pulse oximetry, Hospital Anxiety and Depression Scale (HADS) Stanford Health

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo clear statement on random sequence generation
Allocation concealment (selection bias)Unclear riskNo detail re allocation concealment or how randomisation was done
Blinding of participants and personnel (performance bias)
All outcomes
High riskBoth participants and those delivering the programme were aware of those included in the intervention group
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided
Incomplete outcome data (attrition bias)
All outcomes
High risk

Commenced overall: 20; finished week 8: 14

Attrition: 30%

Selective reporting (reporting bias)Low riskNo protocol paper was registered, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone noted

Faulkner 2010

Methods Study design: RCT (2 groups)
Participants

Setting: recruited from primary care; 16 GP practices in Exeter

Inclusion criteria:

  • Clinical diagnosis of COPD, FEV1/forced vital capacity (FVC) ratio ≤ 70%

  • Smoking history > 10 pack-years

  • Symptoms considered to be inadequately controlled by short-acting bronchodilators

  • Willing and able to undertake a HEPA programme

Exclusion criteria:

  • Body mass index (BMI) > 35 kg/m2

  • Recent respiratory tract infection

  • Oxygen desaturation (SaO2) at rest < 90%

  • Prior participation in a PR programme

  • Serious co-morbid condition that would interfere with regular exercise training

Participant status:

Age: not provided

Gender (M/F): not provided

FEV1 % (pred): not provided

Smokers: all current non-smokers

Participants randomly assigned:

Randomised: 20 (RG: 10; CG: 10)
Analysed:
Rehab:6
Control:8

Interventions

Pulmonary rehabilitation: community (primary care setting)

Exercise programme run in an exercise facility at a university

Aerobic, ULE, LLE, Edu

Duration: 8 weeks once-weekly 90-minute supervised exercise and education

sessions delivered by a qualified exercise and healthcare

practitioner

Usual care: Control group received usual care. All were given tiotropium

Outcomes

Assessment: baseline, 1 week post intervention

CRQ, ISWT, lung information needs questionnaire (LINQ), HADS, 7-day physical activity recall questionnaire, physical self-perception profile (PSPP)

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation sequence, stratified for smoking status, computer generated by a statistician who was independent of the trial
Allocation concealment (selection bias)Low risk

Group allocation was kept concealed

by means of sealed envelopes, which were opened in sequence by the trial researcher following baseline assessment

Blinding of participants and personnel (performance bias)
All outcomes
High risk

It was not possible to blind participants or GPs to

group allocation

Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome assessors not blinded
Incomplete outcome data (attrition bias)
All outcomes
High risk20 randomly assigned; attrition: overall 6 (30%)
Selective reporting (reporting bias)Low riskAll outcomes listed in the paper appear to have been reported
Other biasLow riskNone noted

Fernandez 2009

Methods Study design: RCT (2 groups) performed in a 300-bed district hospital and involving patients with very severe COPD who received oxygen treatment
Participants

Setting: Spanish study; 300-bed district hospital

Inclusion criteria:

  • Diagnosis of very severe COPD

  • Younger than 80 years of age

  • Stable COPD (2 months with no exacerbations)

  • Correct administration of pharmacological treatment

  • Home treatment with oxygen for at least 6 months

Exclusion criteria:

  • Severe cardiovascular pathology, unstable angina or acute myocardial infarction, cerebrovascular accident

  • Physical or psychological disorder that impedes the practice of physical exercise

Participant status:

Age (years ± SD): RG: 66 ± 8; CG: 70 ± 5

Gender (M/F): 1 woman, as the rest were men

FEV1 % (pred ± SD): RG: 33 ± 10; CG: 38 ± 12

FEV1/FVC (± SD): RG: 42 ± 10; CG: 42 ± 11

Participants randomly assigned:

Randomised: 50 (RG: 30; CG: 20)
Analysed:
Rehab:27
Control:14

Interventions

Pulmonary rehabilitation: home based

Aerobic exercise, ULE, LLE, educational material, home physio visits

Duration: received 2 one-hour sessions in the hospital. A minimum of 1 hour of exercise per day was indicated, for a minimum of 5 days per week

Usual care

Outcomes

Assessment: baseline and Imediately post intervention (1 year)

6MWT, SGRQ

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot informed of process: only "randomly divided into 2 groups"
Allocation concealment (selection bias)Unclear riskNot informed
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, unable to blind participants or those delivering the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot informed
Incomplete outcome data (attrition bias)
All outcomes
Low risk

After 1 year, 41 participants completed (83.7%)

Attrition: 16.3%

Selective reporting (reporting bias)Low riskNo protocol paper was found, but all outcomes listed in the paper appear to have been reported
Other biasHigh riskAll men; 1 woman excluded from analysis

Finnerty 2001

Methods Study design: RCT (2 groups)
Participants

Setting: recruited from an out-patient clinical at the Chester Hospital NHS Trust, UK

Inclusion criteria:

  • Long-standing airways disease, classified as COPD

  • Had therapy optimised

  • Given up smoking or prepared to make an active effort to stop smoking during the proposed programme

Exclusion criteria:

  • Dementia or marked agitation or depression evident to investigators

  • Unstable medical condition, such as congestive cardiac failure, cor pulmonale, malignancy or cerebrovascular accident

  • Previously participated in a supervised respiratory rehabilitation programme

Participant status:

Age (years ± Sd ): RG: 70.4 ± 8.0; CG: 68.4 ± 10.4

Gender (M/F): RG: 25/11; CG: 19/10

FEV1 % (pred ± SD): RG: 41.2 ± 19.2; CG: 41.2 ± 16.2

Smoking NO: RG: 2; CG: 6

Participants randomly assigned:

Randomised: 100 (27 did not attend initial assessment)
Analysed:
Rehab:36
Control: 29

Interventions

Pulmonary rehabilitation: 6-Week out-patient-based rehabilitation programme

ULE, LLE, Edu
Duration: 6-Week out-patient-based rehabilitation programme; 2 visits per week: 2-hour education visit and 1-hour exercise visit

Usual care:

Control group reviewed routinely as medical out-patients

Outcomes

Assessment: baseline, 12 weeks and 24 weeks

6-Minute WT, SGRQ

NotesJadad's score = 3
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation was in blocks of 10, using random numbers
Allocation concealment (selection bias)Low riskStudy investigators unaware as to order of treatment group assignment (Cochrane Grade A)
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the exercise programme, unable to blind allocation
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"Both tests were supervised by a blinded observer who subsequently repeated these assessments"
Incomplete outcome data (attrition bias)
All outcomes
High risk

100 randomly assigned; 55 completed (55%)

Only 73 attended for initial assessment

45% attrition

Selective reporting (reporting bias)Low riskNo protocol paper was found, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone identified

Gohl 2006

Methods Study design: RCT (2 groups)
Participants

Setting: out-patient community, training in sports hall; Germany

Inclusion criteria:

  • Included participants suffered from medium to severe COPD

  • 50 to 75 years old

Exclusion criteria:

  • Decompensated coronary heart disease, haemodynamically efficient cardiac arrhythmia or "Kartitiden," insufficiently adjusted arterial hypertension, global respiratory insufficiency, significant partial respiratory insufficiency (paO2 < 50 mmHg and/or SaO2 > 80% at rest), right heart overload due to pulmonary hypertension at rest (accelerative time > 100 m/s)

  • Positive bronchodilation test showing an increase in FEV1 > 15% exacerbated COPD

  • Severe obesity (BMI > 35)

  • Limited capacity on the bicycle ergometer

Participant status:

Age (years ± SD): RG: 62.5 ± 7; CG: 63.2 ± 8.5

Gender (M/F): RG: 6/4; CG: 7/2

FEV1 % (pred ± SD): RG: 53.4 ± 10.7; CG: 53.7 ± 5.8

Participants randomly assigned:

Randomised: 34 (RG: 17; CG 17)
Analysed:
Rehab:10
Control: 9

Interventions

Pulmonary rehabilitation: community, complex long-term training programme

Aerobic exercise, ULE, LLE (escalating levels of activity over time)

Duration: 12-month training programme

Usual care: Control group did not receive therapy

Outcomes

Assessment:

Baseline and 12 months (end of intervention)

6MWT, St. George’s Questionnaire, SF-36, muscle force

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskAssigned to training group or control group at random (chosen by lot)
Allocation concealment (selection bias)Unclear riskNot provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, it is not possible to blind participants or those delivering the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot provided
Incomplete outcome data (attrition bias)
All outcomes
High risk

Commenced: 34; completed: 19; lost: 15

Attrition: 44%

Selective reporting (reporting bias)Low riskNo protocol paper was found, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone noted

Goldstein 1994

Methods

Study design: RCT (2 groups)

Randomisation process: random numbers table

Outcome assessments: blinded

Participants

Setting: in-patient/out-patient; Canada

Inclusion criteria:

  • Severe stable COPD (forced expiratory volume in 1 second (FEV1) < 40% predicted; FEV/forced vital capacity (FVC) < 0-7)

  • Non-smoker for a minimum of 2 months

  • Dyspnoea in 3 or more activities of daily living

  • Ability to communicate in English.

Exclusion criteria:

  • Participated in a supervised respiratory rehabilitation programme within the previous 2 years

  • Associated medical conditions that might limit exercise tolerance or cognitive functioning

Participant status:

Age (years ± SD): RG: 66 ± 7; CG: 65 ± 8

Gender (M/F): RG: 21/17; CG: 17/23

FEV1 % (pred ± SD): RG: 34.8 ±14.5; CG: 34.6 ± 11.8

FEV1 /FVC: RG: 36.8 ± 9.5; CG: 38.8 ± 12.4

Smoking packs (± SD): RG: 58 ± 24; CG: 51 ± 26 per year

Participants randomly assigned:

Randomised: 89
Analysed:
Rehab: 38
Control: 40

Interventions

Pulmonary rehabilitation: in-patient/home based

Aerobics, LLE, ULE, BE, Edu, Psy
Duration: 2 months of in-patient rehabilitation followed by 4 months of out-patient care

Usual care:

Control group received conventional care from general practitioner and respiratory specialist

Outcomes

Assessment: baseline and 24 weeks

6-Minute WT, ICET, SSCET, CRQ, BDI/TDI

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskUsed random tables for allocation
Allocation concealment (selection bias)Low riskStudy investigators unaware as to order of treatment group assignment (Cochrane Grade A)
Blinding of participants and personnel (performance bias)
All outcomes
High riskBoth participants and those delivering the intervention were aware of the allocation of participants
Blinding of outcome assessment (detection bias)
All outcomes
Low riskInvestigator carrying out outcome assessments blinded
Incomplete outcome data (attrition bias)
All outcomes
Low risk

89 randomised and 78 completed

Attrition: 11 (12%)

Selective reporting (reporting bias)Low riskNo protocol paper was found, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone noted

Gomez 2006

Methods

Study design: RCT (3 groups); PR for 3 months and rehabilitation

maintenance for 12 months (RHBM group). Second

group received PR for 3 months only (RHB group) and the third was the control

Participants

Setting: recruited by family physicians from 7 primary care practices in Palma de Mallorca, Spain

Inclusion criteria:

  • 35 to 74 years old

  • Moderate COPD according to GOLD criteria

  • Postbronchodilator results of FEV1/FVC < 0.7, FEV1 values between 50% and 80%

  • Smokers or non-smokers

Exclusion criteria:

  • Any musculoskeletal condition that prevented exercising and walking test assessments

  • Terminal illness or other severe disease at the time of enrolment

Participant status:

Age (years): RG (RHB: 64.1; RHBM: 64.9); CG: 63.4

Gender (M/F): RG: 39/9; CG: 19/4

FEV1 % (pred): RG: 74 (Range 66.5-81.5); CG: 60.1 (Range 55.6-64.4)

FEV1/FVC: RG: 61.2; CG: 59.1

Participants randomly assigned:

Randomised: 97 (33 RHB group and 32 RHBM; control 32)
Analysed:
Rehab:36
Control: 14

Interventions

Pulmonary rehabilitation: community (primary care setting)

Aerobic exercise, ULE, LLE, educational material

Duration: 3 months; rehabilitation maintenance for 12 months

Usual care: Group received routine care without rehabilitation

Outcomes

Assessment:

Baseline, 3 months and 12 months

CRQ, pulmonary function tests, 6MWT

NotesAnalyses completed on 3-month results for combined RHB and RHBM groups
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Centrally administered, computer-generated block randomisation scheme using blocks of 6 with EPIDAT,

stratified according to participating site

Allocation concealment (selection bias)Low riskSee above
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, unable to blind participants and those delivering the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Low riskHealth staff members involved in follow-up (a psychologist and a nurse) were blinded to participant assignment
Incomplete outcome data (attrition bias)
All outcomes
High risk

Out of 97, only 50 at 3-month evaluation

Attrition: 47 (48%)

Selective reporting (reporting bias)Low riskTrial registration (ISRCTN94514482); all outcomes stated in the study appear to have been measured
Other biasLow riskNone noted

Gosselink 2000

Methods Study design: RCT (2 groups)
Participants

Setting: out-patient: referred from an outpatient department in Leuven, Belgium

Inclusion criteria:

  • Younger than 75 years of age; forced expiratory volume in 1 second (FEV1) less than 65% of predicted value

  • Stable clinical condition at inclusion

Exclusion criteria:

  • Infection or COPD exacerbation in the previous 4 weeks

  • Severe medical problems, such as heart failure, myocardial infarction, cerebrovascular disease, cancer or orthopaedic disorders

Participant status:

Age (years ± SD): RG: 60 ± 9; CG: 63 ± 7

Gender (M/F): RG: 31/6; CG: 30/3

FEV1 % (pred ± SD): 41 ±16; RG: CG: 43 ±12

Participants randomly assigned:

Randomised: 100
Analysed:
Rehab: 34
Control: 28

Interventions

Pulmonary rehabilitation: outpatient sessions; cycling, treadmill walking, stair climbing and peripheral muscle training

LLE, ULE

Duration: 24 weeks: 3 times a week in the first 3 months; during subsequent 3 months, training

frequency was reduced to twice weekly. Each session had a duration of 1.5 hours

Usual care: usual medical care

Outcomes

Assessment: baseline and at 6 months and 18 months

6-Minute WT, ICET, CRQ

Isometric quadriceps strength, inspiratory and expiratory muscle strength

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation process: sealed envelopes
Allocation concealment (selection bias)Low riskStudy investigators unaware as to order of treatment group assignment (Cochrane Grade A)
Blinding of participants and personnel (performance bias)
All outcomes
High riskBoth participants and those delivering the intervention were aware of the allocation of participants
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome assessments: not blinded
Incomplete outcome data (attrition bias)
All outcomes
High risk

Commenced: 100; 6 months: 62; remaining: 62%

Attrition: 38%

Selective reporting (reporting bias)Low riskNo protocol paper was found, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone noted

Gottlieb 2011

Methods

Study design: RCT (2 groups)

Single-centre, randomised, placebo-controlled, unblinded clinical trial

Participants

Setting: patients listed with 56 GPs in Copenhagen, Denmark

Inclusion criteria:

  • Diagnosis of moderate COPD

  • Motivation for pulmonary rehabilitation

Exclusion criteria:

  • Co-morbidity contraindicating rehabilitation

  • Participation in pulmonary rehabilitation within the past year

  • Cognitive disorders limiting ability to participate in physical training and educational sessions

Participant status:

Age (years, Range): RG: 74.1 (66–82); CG: 73.2 (67–88)

Gender (M/F): RG: 7/15; CG: 7/13

FEV1 % (pred ± SD): RG: 64.27 ± 7.9; CG: 67.05 ± 8.8

FEV1 /FVC (± SD): RG: 0.54 ± 0.07; CG: 0.6 ± 0.1

Smokers: RG: 11; CG: 9

Participants randomly assigned:

Randomised: 61 (RG: 35; GG: 26)
Analysed:
Rehab: 22
Control: 20

Interventions

Pulmonary rehabilitation: community

Aerobic exercise, ULE, LLE, Edu, follow-up call

Duration: 7 weeks; two 90-minute sessions a week

Usual care: standard COPD care received from GP

Outcomes

Assessment: baseline and 6 months

6MWT, MRC, SGRQ

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation was performed using sealed opaque envelopes randomly assigned to participants
Allocation concealment (selection bias)Low risk 
Blinding of participants and personnel (performance bias)
All outcomes
High riskBoth participants and those delivering the intervention were aware of the allocation of participants
Blinding of outcome assessment (detection bias)
All outcomes
High riskUnblinded clinical trial
Incomplete outcome data (attrition bias)
All outcomes
High risk

61 randomly assigned, 42 completed (68%)

Attrition: 32%

Selective reporting (reporting bias)Low riskStudy authors appear to have reported what they said they would at the beginning of the article
Other biasLow riskNone identified

Griffiths 2000

Methods

Study design:

RCT (2 groups)

Participants

Setting: recruited from local hospitals and local general practices to participate; Wales

Out-patient + Home-based follow-up

Inclusion criteria:

  • FEV1 < 60% of predicted with < 20% reversibility

  • No change in symptoms or medication for 2 months

Exclusion criteria:

  • Could not walk

  • Severe sensory or cognitive impairment or symptomatic ischaemic heart disease

Participant status:

Age (years ± SD): RG: 68.2 ± 8.2; CG: 68.3 ± 8.1

Gender (M/F): RG: 57/36; CG: 54/37

FEV1 % (pred ± SD): RG: 39.7 ±16.2; CG: 39.4 ±16.4

FEV1 /FVC (± SD): RG: 0.49 ± 0.13; CG: 0.49 ± 0.13

Smoking, packs per year: RG: 43.5 (31.1); CG: 45.7 (21.9)

Participants randomly assigned:

Randomised: 200
Analysed:
Rehab: 93
Control: 91

Interventions

Pulmonary rehabilitation: multi-disciplinary, out-patient/home based

LLE, ULE, Edu, Psy, NS, SmC
Duration: 6 weeks, 3 half-days per week; session 2 hours long; in addition encouraged to follow a home exercise routine

Usual care:

continued with usual out-patient or primary care follow-up

Outcomes

Assessment: baseline and follow-up for 1 year

Shuttle WT, CRQ, SF-36, SGRQ, HADS

NotesJadad's score = 2
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation process: sealed envelopes
Allocation concealment (selection bias)Low riskStudy investigators unaware as to order of treatment group assignment (Cochrane Grade A)
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, it is not possible to blind participants or those delivering the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessments: blinded
Incomplete outcome data (attrition bias)
All outcomes
Low risk

200 commenced; 180 completed

Attrition: 10%

Selective reporting (reporting bias)Low riskNo protocol paper was found, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone noted

Gurgun 2013

Methods Study design: RCT (3 groups)
Participants

Setting: patients from Ege University Hospital Turkey outpatient clinic admitted to the PR unit between January 2010 and November 2010

Inclusion criteria:

  • Diagnosis of COPD

  • Evidence of nutritional depletion defined as meeting at least 1 of the following criteria (10):

    • Body mass index (BMI/height squared) ≤ 21 kg/m2, Fat Free Mass Index (FFM/height squared) ≤ 15 kg/m2 for women or 16 kg/m2 for men; or

    • BMI ≤ 25 kg/m2 plus weight loss of at least 5% in 1 month, or at least 10% in 6 months, before admission

Exclusion criteria:

  • Disabling conditions (neuromuscular, malignant disorders, unstable cardiovascular disease, orthopaedic problems, severe pulmonary hypertension)

  • Unwilling to complete the programme

  • Suffering from acute exacerbation over the previous 4 weeks

  • Lack of motivation or poor compliance

Participant status:

Age (years ± SD): RG: [PRNS: 64.0 ± 10.8; PR: 66.8 ± 9.6]; CG: 67.8 ± 6.6

Gender (M/F): RG: [PRNS 13/2; PR: 15/0]; CG: 16/0

FEV1 % (pred ± SD): RG:[ PRNS: 41.9 ± 10.8; PR: 41.9 ± 13.2]; CG: 39.3 ± 9.3

FEV1 /FVC (± SD): RG: [PRNS: 53.4 ± 15.8; PR: 49.0 ± 6.7]; CG: 46.7 ± 7.2

Participants randomly assigned:

Randomised: 46
Analysed:
Rehab: PRNS: 15; PR: 15
Control: 16

Interventions

Pulmonary rehabilitation: out-patient programme (hospital based). Pulmonary rehabilitation and nutritional support (Pr Alone (PR) or PR and nutritional support (PRNS))

Aerobic exercise, ULE, LLE, educational material, nutritional support

Duration: 8 weeks

Usual care: usual medical standard care

Outcomes

Assessment: baseline and following 8 weeks of PR

MRC, 6MWT, ISWT, ESWT, SGRQ, HADS

NotesReported results using combined group PR + PRNS
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskEligible patients were randomly assigned in a 1:1:1 ratio with the use of sealed envelopes
Allocation concealment (selection bias)Low riskAs above
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, unable to blind participants or those delivering the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo attrition reported
Selective reporting (reporting bias)Low riskNo protocol paper was found, but all outcomes listed in the paper appear to have been reported
Other biasHigh riskAll men; 15 in PR group, 15 in control. 2 women in PRNS

Güell 1995

Methods

Study design: RCT (2 groups)

Randomisation process: random numbers table

Outcome assessments: blinded

Participants

Setting: out-patient: secondary care respiratory clinic in Barcelona

Inclusion criteria:

  • Participants older than 75 years

  • FEV1 70% of reference values, FEV1/FVC 65%, PaO2 55 mmHg at rest

  • No indication for prescribing home oxygen therapy

Exclusion criteria:

  • Experienced an exacerbation or hospitalised in the previous month

  • Clinically apparent heart disease or relevant bone or joint disease

Participant status:

Age (years): RG: 66 (7); CG: 65 (6)

Gender (M/F): all men

FEV1 % (pred): RG: 31 (12); CG: 39 (14)

Participants randomly assigned:

Randomised: 60
Analysed:
Rehab: 29
Control: 27

Interventions

Pulmonary rehabilitation (out-patient and home based; 3 months of outpatient breathing retraining and chest physiotherapy; 3 months of daily supervised exercise)

LLE, BE, PD
Duration: 6 months (3 months of PR; participants were included in two 30-minute sessions each week (breathing retraining) combined with home exercise programme). Second 3-month period (exercise training): five 30-minute sessions weekly on a stationary cycle ergometer

Usual care: Control group received standard care

Outcomes

Assessment: baseline and 3, 6, 9, 12, 18 and 24 months

6MWT, ICET, CRQ

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskUsed random number tables; letter sent to LaCasse
Allocation concealment (selection bias)High riskNo concealment
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnable to blind both participants and those delivering the intervention because of the nature of the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Low riskTechnicians who collected data for outcome measures at every visit, as explained below, were blinded to participants' allocation to PR or control groups
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll 60 participants completed 6 months of follow-up
Selective reporting (reporting bias)Low riskNo protocol paper was found, but all outcomes listed in the paper appear to have been reported
Other biasHigh riskAll men only

Güell 1998

Methods Study design: RCT (2 groups)
Participants

Setting: out-patient

Inclusion criteria:

  • Age ≤ 75 years; FEV1 < 70% of reference values; FEV1/FVC ratio < 65%; Pao2 > 55 mmHg at rest

  • No indications for home oxygen therapy

  • No exacerbation or hospitalisation in the previous 2 months

Exclusion criteria:

  • Psychiatric disturbance

  • Heart disease

  • Relevant bone or joint disease

Participant status:

Age (years ± SD): 68 ± 8; CG: 66 ± 8

Gender (M/F): RG: 16/2; CG: 17/0

FEV1 % (pred ± SD): RG: 32% ±11; CG: 38% ±15

Participants randomly assigned:

Randomised: 40
Analysed:
Rehab: 18
Control: 17

Interventions

Pulmonary rehabilitation: 2 months of chest physio and 2 months of muscle training

LLE, IMT
Duration: 8 weeks

Usual care

Outcomes

Assessment: baseline and post intervention (8 weeks)

CRQ, 6MWT, dyspnoea, maximal workload

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom numbers table
Allocation concealment (selection bias)High risk

Randomisation was not concealed, but the likelihood of bias

introduced by unconcealed randomisation was reduced by recruitment of consecutive patients

Blinding of participants and personnel (performance bias)
All outcomes
High riskUnable to blind both participants and those delivering the intervention because of the nature of the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Low riskTechnicians who collected data were blinded to participant allocation to the PRG or the CG, as were data analysts, until the analysis was deemed complete
Incomplete outcome data (attrition bias)
All outcomes
Low riskCommenced: 40; attrition: 5 (12%)
Selective reporting (reporting bias)Low riskNo protocol paper was found, but all outcomes listed in the paper appear to have been reported
Other biasLow riskNone noted

Hernandez 2000

Methods

Study design: RCT (2 groups)

Randomisation process: random numbers table

Outcome assessments: blinded

Participants

Setting: home-based; Seville, Spain

Inclusion criteria:

  • COPD diagnosed in accordance with European Respiratory Society Consensus Statement

  • Stable phase of disease with optimal drug management

Exclusion criteria:

  • Evidence of ischaemic heart disease, severe or uncontrolled systemic arterial hypertension, alterations in the thoracic cage

  • Neuromuscular disorders or intermittent claudication or osteoarticular lesions in the lower extremity that could affect normal ambulation

  • Acute exacerbation in the course of the programme excluded

Participant status:

Age (years ± SD): RG: 64.3 ± 8.3 ; CG: 63.1 ± 6.9

Gender (M/F): RG: 20/0; CG: 17/0

FEV1 % (pred ± SD): RG: 71.1 ± 18.9; CG: 74.7 ± 14.7

FEV1 /FVC (SD): RG: 47 ± 9.9; CG: 42.3 ±12

Participants randomly assigned:

Randomised: 60
Analysed:
Rehab: 20
Control: 17

Interventions

Pulmonary rehabilitation: home rehabilitation programme; training intensity was determined individually

LLE
Duration: 12 weeks

Usual care: Control group participants (standard medical treatment alone; also made visits to the hospital every 2 weeks for a clinical checkup and for supervision of treatment)

Outcomes

Assessment: baseline and 12 weeks

ICET, Shuttle WT, CRQ, BDI/TDI

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom numbers table used
Allocation concealment (selection bias)Unclear riskNo details provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnable to blind both participants and those delivering the intervention because of the nature of the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Low riskInvestigators were blinded (letter from study author)
Incomplete outcome data (attrition bias)
All outcomes
High risk

60 randomly assigned; 37 completed (61.6%)

Attrition: 38.3%

Selective reporting (reporting bias)Low riskIt appears that all outcomes stated at the outset of the article were reported in the findings
Other biasLow riskParticipants who were excluded because they did not meet the criteria appear to have been excluded after randomisation

Hoff 2007

Methods Study design: RCT (2 groups)
Participants

Setting: Norway

Inclusion criteria:

  • Clinical definition of COPD with FEV1/FVC < 70% and FEV1 < 60% predicted

  • Between 40 and 70 years of age

Exclusion criteria:

  • History of cardiovascular disease, lung disease other than COPD, diabetes mellitus or other metabolic diseases, malignant disease, pregnancy

  • Corticosteroid use in the past 6 months

  • Respiratory tract infection within the past 4 weeks

Participant status:

Age (years ± SD): RG: 62.8 ± 1.4; CG: 60.6 ± 3.0

Gender (M/F): RG: 4/2; CG: 4/2

FEV1/FVC (± SD): RG: 49.9 ± 4.6; CG: 45.2 ± 6.0

Participants randomly assigned:

Randomised:
Analysed: 12
Rehab: 6
Control: 6

Interventions

Pulmonary rehabilitation: lab-based maximal strength training

(seated horizontal leg press apparatus)

LLE

Duration: 8 weeks

Usual care: Control group continued normal daily living with modest regular activity, as recommended by pulmonary physician

Outcomes

Assessment: baseline and week 8

Incremental cycle ergometry

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information provided
Allocation concealment (selection bias)Unclear riskInsufficient information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, unable to blind both participants and those delivering the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information provided
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll participants completed the study protocol with no adverse effects, and the MST group completed 100% of the planned training
Selective reporting (reporting bias)Low riskNo protocol was identified. All outcomes identified in the methods section of the paper were reported in the results
Other biasLow riskNone noted

Jones 1985

Methods Study design: RCT (3 groups: exercise, resistive breathing, control)
Participants

Setting: home based; recruited from a chest clinic in Dunedin, New Zealand

Inclusion criteria:

  • Fewer than 75 regular attendees at clinics

  • Severe irreversible airflow obstruction; FEV1 < 1.2 and < 20% improvement after bronchodilator

Exclusion criteria:

  • Angina pectoris, left and right heart failure, neuromuscular or skeletal disease that limited exercise

Participant status:

Age (years ± SD ): RG: 63.8 ± 6.09; CG: 62.7 ± 8.36

Gender (M/F): RG: 6/2; CG: 1/5

FEV1 % (pred ± SD): RG: 0.78 ± 0.27; CG: 0.68 ± 0.12

Smoking: RG: 8; CG: 5

Participants randomly assigned:

Randomised: 30 (exercise 11, breathing 11, control 8)
Analysed:
Rehab: exercise: 8, breathing: 7

Control: 6

Interventions

Pulmonary rehabilitation:

Simple physical exercises at home under the supervision of a physiotherapist and every 2 weeks in the gymnasium

LLE, ULE
Duration: 10 weeks

Usual care: placebo respiratory device and usual care

Outcomes

Assessment: baseline and 10 weeks

12-Minute WT, ICET, SSCET, daily diary, Lubin Affectometer

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation process: drawing lots
Allocation concealment (selection bias)High riskNo concealment apparent
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, unable to blind both participants and those delivering the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessments: not blinded for ICET, blinded for the others
Incomplete outcome data (attrition bias)
All outcomes
High risk

Commenced: 19; completed: 14 (73.7%)

Attrition: 26.3%

Selective reporting (reporting bias)Low riskNo protocol was identified. All outcomes identified in the methods section of the paper are reported in the results
Other biasHigh riskControl received a placebo respiratory device, which may have an impact

Karapolat 2007

Methods Study design: RCT (2 groups)
Participants

Setting: Dept Chest Medicinein Izmir, Turkey

Inclusion criteria:

  • FEV1 between 30% and 80% of predicted value

  • Clinical condition stable at the time of inclusion

  • No infections or COPD exacerbations in the preceding 4 weeks

Exclusion criteria:

  • Severe medical problems such as heart failure, recent myocardial infarction, cerebrovascular disease, orthopaedic problems and severe liver or kidney problems

Participant status:

Age (years ± SD): RG: 64.81 ± 9.4; CG: 67.21 ± 6.72

Gender (M/F): RG: 21/5; CG: 18/1

FEV1 %: RG: 55.50%; CG: 58%

Participants randomly assigned:

Randomised: 54
Analysed:
Rehab: 26
Control: 19

Interventions

Pulmonary rehabilitation: out-patient programme

Aerobic exercise, ULE, LLE, breathing exercises, educational material

Duration: 8 weeks

Education component: 16 sessions of discussion (1 hour/wk)

Exercise component: 3 times a week

Usual care

Outcomes

Assessment: baseline, week 8 and week 12

6MWT, SGRQ

NotesWeek 8 data used for analysis
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskParticipants were randomly assigned in a 1:1 ratio with the use of sealed envelopes
Allocation concealment (selection bias)Low risk 
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, unable to blind both participants and those delivering the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot informed
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Commenced: 49; completed: 45

Attrition: 18.17%

Selective reporting (reporting bias)Low riskNo protocol was identified. All outcomes identified in the methods section of the paper are reported in the results
Other biasLow riskParticipants who were excluded because they did not meet the criteria appear to have been excluded after randomisation

Lake 1990

Methods Study design: RCT (4 groups); participants were randomly assigned to a control group and to 3 actively trained groups
Participants

Setting: intervention delivered in outpatient hospital setting; Perth, Western Australia

Inclusion criteria:

  • Severe COPD

  • Condition stable

  • Demonstrated minimal bronchodilator response

  • Receiving maximal medical treatment

  • Never been involved in an exercise programme

Exclusion criteria:

  • Unstable cardiac disease; musculoskeletal disability preventing exercise; cor pumonale; respiratory muscle fatigue (abdominal paradox)

  • Acute illness

  • Communication or transport difficulties

Participant status:

Age (years ± SD ): RG: 66.3 ± 6.8; CG: 65.7 ± 3.5

Gender (M/F): RG: 6/1; CG: 4/3

FEV1 % (pred ± Sd): RG: 0.97 ± 0.29; CG: 0.83 ± 0.25

Participants randomly assigned:

Randomised: 28
Analysed:
Rehab: 7
Control: 7

Interventions

Pulmonary rehabilitation: out-patient hospital based: 4 groups (combined exercise: 7; upper limb: 6; lower limb: 7; control)

LLE or ULE or both
Duration: 8 weeks (1 hour 3 times per week)

Usual care

Outcomes

Assessment: baseline and immediately after the 8 weeks

6MWT, ICET, IAET
Bandura Scale of Well-being

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation process: randomisation chart
Allocation concealment (selection bias)Unclear riskNo allocation concealment discussed
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, unable to blind participants and those delivering the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessments: blinded for ICET, not blinded for 6MWT
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Commenced: 28; finished: 26 (92.9%)

Attrition: 7.1%

Selective reporting (reporting bias)Low riskNo protocol was identified. All outcomes identified in the methods section of the paper were reported in the results
Other biasUnclear riskNone noted

Lindsay 2005

Methods Study design: RCT (2 groups)
Participants

Setting: Lek Yuen Family Medicine Teaching Clinic, Hong Kong,

and the Family Medicine Training Centre of the Prince of Wales Hospital

Inclusion criteria:

  • COPD: FEV1 < 80% predicted and FEV1/FVC ratio < 70% that does not change markedly over several months

Exclusion criteria:

  • Could not walk; suffered from severe sensory or cognitive impairment, symptomatic ischaemic heart disease; or

  • Were on supplemental oxygen

  • Further exclusion criteria included glaucoma, prostate problems, pregnancy, breast-feeding, intolerance to ipratropium, bladder outlet problems and severe kidney problems, as these people would not be able to use tiotropium

Participant status:

Age (years ± SD): RG: 69.5 ± 9.3; CG: 69.8 ± 10.3

Gender (M/F): RG: 20/5; CG: 18/7

FEV1 % (pred ± SD): RG: 0.9 ± 0.3; CG: 0.8 ± 0.4

Current smoker: RG 3 (12%); CG: 7 (28)

Participants randomly assigned:

Randomised: 50 (25 each group)
Analysed:
Rehab: 21
Control: 20

Interventions

Pulmonary rehabilitation: community (primary care setting)

Aerobic exercise, ULE, LLE, educational material, home physio visits

Duration: 6 weekly sessions of psychoeducation, each lasting for 2 hours

Usual care: given tiotropium, which is considered standard usual care

Outcomes

Assessment: baseline, start of PRP, end of PRP and 3 months

6MWD, spirometry, CRQ

NotesFor analysis, used mean and standard deviation of all other studies, as did not provide SD
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot provided
Allocation concealment (selection bias)Unclear riskNot provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, unable to blind participants and those delivering the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot provided
Incomplete outcome data (attrition bias)
All outcomes
Low risk

50 randomly assigned; drop-out: 9

Attrition: 18%

Selective reporting (reporting bias)Low riskNo protocol was identified. All outcomes identified in the methods section of the paper were reported in the results
Other biasLow riskNone noted

Liu 2012

Methods

Study design: RCT (3 groups)

Single-blind

Participants

Setting: conducted in Hong Kong, in the care of respiratory specialists of Jiangs Province Hospitals from October 2008 to October 2010

Inclusion criteria: COPD severity level at GOLD stages I and II

Exclusion criteria: no serious co-morbidities (e.g. pulmonary tuberculosis, emphysema, congestive heart failure)

Participant status:

Age (years± SD):RG:[ HQG: 61.82 ± 7.69; PRG: 61.34 ± 8.3]; CG: 62.2 ± 6.34

Gender (M/F): RG:[HQG: 78%/22%; RG: 72%/28%]; CG: 80%/20%

FEV1 % (pred ± SD ): [HQG: 74.43 ± 12.93; PRP: 75.31 ± 12.84;]

FEV1 /FVC (± SD): RG[HQG: 60.73 ± 6.18; PRP: 61.27± 5.86]; control: 61.43 ± 6.17

Never smoked: HQG: 37.3%; PRP: 43.8%; control: 34.3%

Participants randomly assigned:
Randomised: 132 (PR: 36; Qiqong: 60; control: 36)

Analysed:
Rehab: 32

Control: 35

Interventions

Pulmonary rehabilitation: combined in-patient and/or home/community/out-patient
Aerobic exercise, ULE, LLE, peer support

Duration: 6 months; then encouraged to participate in peer-led weekly walking and ball game activities thrice a week, 1 hour each time, for 6 months

Usual care: received health education and was advised to continue exercising alone

Outcomes

Assessment: baseline and 6 months

6MWD, Zhongshan COPD Questionnaire for QoL, immune cell factor,

hospital admissions

NotesUsed only exercise group for analysis
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskParticipant allocation list was drawn on the basis of random order of the block ("H-H-H-P-P-C-C") for 20 times, until a list of 140 individuals in a specific order was obtained
Allocation concealment (selection bias)Low riskNot provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, participants and those delivering the programme could be randomly assigned
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAll outcome assessors were blinded to each participant’s allocated group, as well as to the objectives of the study, to minimise bias
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Randomised: 132 (control: 36; PR: 36; Qigong: 60)

118 included in the final analysis (control: 35; PR: 32; Qigong: 51)

So lost 14 overall (89%) participated; attrition: 11%

Selective reporting (reporting bias)Low riskNo protocol was identified, but all results re stated outcomes seem to have been included
Other biasLow riskNone noted

McGavin 1977

Methods

Study design:

RCT (2 groups)

Participants

Setting: home based; New Delhi, India

Inclusion criteria:

  • Younger than 70 years of age

  • Chronic bronchitis according to the criteria of the Medical Research Council

Exclusion criteria:

  • Demonstrating reversibility post salbutamol

  • Taking corticosteroid medication

  • Patients with angina pectoris, intermittent claudication and disabling musculoskeletal disorders

Participant status:

Age (years ± SD ): RG: 61.4 ± 5.6, CG: 57.2 ± 7.9

Gender (M/F): RG: 12/0; CG: 12/0

FEV1 % (pred ± SD ): RG: 0.97 L ± 0.33; CG: 1.15 L ± 0.72

FEV1 /FVC: RG:CG

Participants randomly assigned:

Randomised: 28
Analysed:
Rehab: 12
Control: 12

Interventions

Pulmonary rehabilitation: home-based training programme consisting of graded stair-climbing exercises tailored to suit the ability of the individual

LLE
Duration: continuous, once a day, at least 5 days a week

Usual care:

Control group did not receive exercise instructions or an out-patient check at 2 weeks

Outcomes

Assessment: baseline and mean 14 weeks control; mean 19 weeks intervention

12-Minute WT, ICET
Interviews

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskUsed random numbers tables
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, participants and those delivering the programme could be randomly assigned
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome assessments: not blinded (letter from study authors)
Incomplete outcome data (attrition bias)
All outcomes
Low risk

28 started; 24 finished (85.7%)

Attrition: 14.28%

Selective reporting (reporting bias)Low riskNo protocol was identified, but all stated results re outcomes seem to have been included
Other biasLow riskNone identified

McNamara 2013

Methods

Study design:

RCT (3 groups, land based, water based, control)

Participants

Setting: patients referred to outpatient pulmonary rehabilitation

at an Australian tertiary public hospital

Inclusion criteria:

  • Diagnosis of COPD

  • In a stable phase

  • Presence of 1 or more physical co-morbidities (including musculoskeletal conditions affecting lumbar spine or lower limbs, 1 or more lower limb joint replacements restricting mobility and/or range of motion or peripheral vascular disease or neurological condition such as stroke or obesity with body mass index (BMI) > 32 kg/m2)

Exclusion criteria:

  • Unstable cardiac disease

  • Contraindications to water-based therapy such as uncontrollable incontinence or open wounds

  • Completed pulmonary rehabilitation in the past 12 months

  • Cognitive decline

  • Inability to understand oral and written English

Participant status:

Age (years ± SD): RG:[ water: 72 ± 10; land: 73 ± 7]; CG: 70 ± 9

Gender (M/F): RG: 15/23; CG: 7/8

FEV1 % (pred ± SD): RG: [WB: 60 ± 10; LB: 62 ± 15]; CG: 55 ± 20

FEV1 /FVC: RG: [WB: 59 ± 9; LB: 58 ± 9]; CG: 53 ± 13

Current smokers: RG: [WB: 3; LB: 1]; CG: 2

Participants randomly assigned:

Randomised: 53 (control: 15; land based: 20; water based: 18)
Analysed:
Rehab: land based: 15; water based: 15
Control: 15

Interventions

Pulmonary rehabilitation: out-patient programme: hospital gymnasium; participants walked at an intensity of 80% of the average 6MWT speed over ground or on a treadmill. Water-based exercise training group exercised in a hospital hydrotherapy pool

Aerobic exercise, ULE, LLE

Duration: 8 weeks; three 60-minute sessions a week of supervised exercise led by the same experienced physiotherapist

Usual care:

Control group participants received usual medical care and no exercise training. They were asked not to alter their exercise level over the study period

Outcomes

Assessment:

baseline and 8 weeks

CRDQ, 6MWT, ISWT, ESWT

NotesPlease note: Combined intervention groups of land and water used for analysis
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Randomly assigned by an investigator external to the study using

a Web-based computer-generated sequence

Allocation concealment (selection bias)Low risk

Concealed allocation achieved with the use of opaque

envelopes

Blinding of participants and personnel (performance bias)
All outcomes
High risk

As a result of the nature of the exercise interventions, it

was not possible to blind therapists or participants to allocation

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAssessor blinding
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Commenced: 53; analysed: 55

Attrition: 8 (15%)

Selective reporting (reporting bias)Low risk

Registered on www.anzctr.org.au (ACTRN0126000408583)

Primary outcomes and all planned secondary outcomes appear to have been reported

Other biasLow riskNone noted

Mehri 2007

Methods Study design: RCT (2 groups)
Participants

Setting: Iran

Inclusion criteria:

  • COPD as recommended in GOLD

Exclusion criteria:

Participant status:

Age (years ± SD): RG: 52.1 ± 10.7; CG: 52.17 ± 11.6

Gender (M/F): RG: 11/9; CG: 7/11

FEV1 % (pred): RG:CG: not available

FEV1 /FVC: RG:CG: not available

Participants randomly assigned:

Randomised: 38 (RG: 20, CG: 18)
Analysed:
Rehab: 20
Control: 18

Interventions

Pulmonary rehabilitation: outpatient clinic, exercised on a treadmill

Aerobic exercise, ULE, LLE

Duration: 4 weeks, 2 times a week

Usual care: Control group completed no treadmill exercise training

Outcomes

Assessment:

baseline and 4 weeks

VO2 peak, based on the Rockport formula

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo information provided
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High risk

As a result of the nature of the exercise interventions, it

was not possible to blind therapists or participants to allocation

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo attrition reported
Selective reporting (reporting bias)Low riskNo protocol was identified, but all stated results re outcomes appear to have been included
Other biasLow riskNone noted

Mendes De Oliveira 2010

Methods

Study design:

RCT (3 groups); outpatient group that performed all activities at the clinic, home-based group that performed activities at home and control group

Participants

Setting: private pulmonology clinic in Cascavel (southern Brazil)

Inclusion criteria:

  • COPD based on GOLD

  • Clinical stability in the 8 weeks before the study

Exclusion criteria:

  • Hospitalisation; COPD instability

  • Presence of neuromuscular disease, associated respiratory disease, orthopaedic or neurological disease that affected gait

  • Recent impairment due to co-morbidities, such as myocardial infarction, heart failure, stroke or neoplasm; prior pneumonectomy or other thoracic surgery

Participant status:

Age (years): RG: [home: 66.4; outpatients: 71.3]; CG: 70.8

Gender (M/F): RG:[ home: 27/6; outpatients: 19/4]: CG: 19/10

FEV1 % (pred): RG:[ home 47.5 ; outpatient 51.5 ]; CG: 41.4

Participants randomly assigned:

Randomised: 117
Analysed:
Rehab: home: 33; outpatient: 23
Control: 29

Interventions

Pulmonary rehabilitation: outpatient clinic or home based

Aerobic exercise, ULE, LLE, education

Duration: 12 weeks, 3 times a week

Usual care: Control group performed no PR

Outcomes

Assessment:

baseline and 12 weeks

MRC, BODE Index, 6MWT

NotesCombined 2 intervention groups for the analysis
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomly assigned electronically by a computer to 3 groups
Allocation concealment (selection bias)Low riskNot provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, unable to blind participants and those delivering intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk

2 duly trained healthcare professionals were responsible for the evaluations, which were performed by the same evaluators for all

participants

Incomplete outcome data (attrition bias)
All outcomes
High riskLoss: 32; attrition: 27%
Selective reporting (reporting bias)Low riskNo protocol was identified, but all stated results re outcomes appear to have been included
Other biasLow riskNone noted

Nalbant 2011

Methods

Study design:

RCT (2 groups)

Participants

Setting: nursing home residents in Turkey

Inclusion criteria:

  • 60-85 years of age

  • Diagnosed with COPD

Exclusion criteria:

  • Systemic diseases affecting the respiratory system, requiring treatment

  • Arrhythmias and/or congestive heart failure, allergic rhinitis, atopy, with a history of malignancy

  • Continuous oxygen therapy

  • Acute COPD attacks in the period, steroid

  • Narcotic analgesics and chronic alcohol

Participant status:

Age (years): RG: 73.5; CG: 68

Gender (M/F): RG: 11/3; CG: 13/2

FEV1/FVC (Range): RG: 58.5 (48-65); CG: 57 (44-66)

Participants randomly assigned:

Randomised: 29 (RG: 14, CG: 15)
Analysed:
Rehab: 10
Control: 11

Interventions

Pulmonary rehabilitation:

Aerobic exercise, ULE, LLE, educational material

Duration: 6 months, 3 days a week for 1.5 hours

Usual care

Outcomes

Assessment:

baseline, 3 months and 6 months

6MWT, lower extremity strength test

NotesNote: Only medians and ranges provided, so cannot be used in analysis
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot provided
Allocation concealment (selection bias)Unclear riskNot provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, unable to blind participants and those providing intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot provided
Incomplete outcome data (attrition bias)
All outcomes
High risk

29 people were randomly assigned

21 completed; loss of 8 people

Attrition: 28%

Selective reporting (reporting bias)Low riskNo protocol was identified, but seems to have included all results re outcomes stated
Other biasLow riskNone noted

O'Shea 2007

Methods

Study design:

RCT (2 groups); single- blind randomised trial

Participants

Setting: 4 sites including 3 regional health services and 1 large metropolitan hospital; Australia

Inclusion criteria:

  • Diagnosis of COPD

Exclusion criteria:

  • Respiratory condition other than COPD

  • Unstable medical conditions limiting performance of resistance exercise

  • PR in previous 12 months

Participant status:

Age (years ± SD): RG: 66.9 ± 7: CG: 68.4 ± 9.9

Gender (M/F): RG:CG

FEV1 % (pred): RG: 49; CG: 52

FEV1/FVC: RG: 50; CG: 49

Hx smoking per day: RG: 40; CG: 26.5

Participants randomly assigned:

Randomised: 54 (27 to each group)
Analysed:
Rehab: 20
Control: 24

Interventions

Pulmonary rehabilitation: outpatient clinic and home based: under the supervision of an experienced physiotherapist; progressive resistance exercise programme

ULE, LLE

Duration: 12 weeks: 1 session per week facilitated, 2 sessions performed independently at home

Usual care: Control group received no intervention

Outcomes

Assessment:

baseline and 3 months and 6 months

CRDQ, 6MWT, Timed Up and Go Test, Grocery Shelving Test, Patient-Specific Functional Scale, participation restrictions: London Handicap Scale, hand-held dynamometry

NotesUtilised data at 3 months for analysis
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskGenerated by member of the research team not involved in participant recruitment
Allocation concealment (selection bias)Low riskConcealed allocation
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and those delivering the intervention were aware of which individuals were included in the intervention group
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAssessor blinding
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Commenced: 54; loss: 44

Attrition: 19%

Selective reporting (reporting bias)Low riskNo protocol was identified, but all results re stated outcomes appear to have been included
Other biasHigh riskAll male

Ozdemir 2010

Methods

Study design:

RCT (2 groups): water based exercise (WE) and control

Participants

Setting: Chest Diseases Outpatient Clinic between April 2006 and

November 2006; Turkey

Inclusion criteria:

  • Moderate or severe COPD

Exclusion criteria:

  • Without respiratory failure

  • Severe hypertension

  • Dizziness or fainting during exercise

  • Severe congestive heart failure that could not be controlled

  • Under treatment

  • Unstable coronary artery disease, terminal liver failure

  • Psychiatric instability, behavioural disorder

  • Suspected bronchial asthma

  • Ongoing infectious disease

Participant status:

Age (years ± SD): RG: 60.9 ± 8.8; CG: 64.1 ± 8.9

Gender (M/F): all male

FEV1 % (pred ± SD): RG: 54.5 ± 15.6; CG: 54.1 ± 20.2

FEV1/FVC (± SD) : RG: 56.0 ± 10.5; CG: 54.6 ± 9.1

Smoker: RG: 5 (20%); CG: 6 (24%)

Participants randomly assigned:

Randomised: 50 (25 in each)
Analysed:
Rehab: 25
Control: 25

Interventions

Pulmonary rehabilitation: out-patient; water-based exercise (WE)

Aerobic exercise, ULE, LLE

Duration: 4-Week water-based pulmonary rehabilitation for 35 minutes 3 times a week

Usual care: received only medical therapy

Outcomes

Assessment:

baseline and 1 month

Spirometry, 6MWT, CRDQ, HAD Scale, arterial blood gas examination

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskAccording to "tables of random numbers"
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo attrition reported
Selective reporting (reporting bias)High riskNo protocol was identified, but results for CRQ of rehabilitation group were not provided
Other biasLow riskNone noted

Paz-Diaz 2007

Methods Study design: RCT (2 groups)
Participants

Setting: recruited from the pulmonary clinic at the University Hospital of Caracas

Inclusion criteria:

  • COPD diagnosed

  • Clinically stable

  • Receiving optimal medical therapy

Exclusion criteria:

  • Not clinically stable

Participant status:

Age (years ± SD): RG: 67 ± 5; CG: 62 ± 7

Gender (M/F): RG: 6/4; CG: 12/2

FEV1 % (pred ± SD): RG: 34 ± 11; CG: 30 ± 9

FEV1/FVC (± SD): RG: 39 ± 7; CG: 30 ± 9

Participants randomly assigned:

Randomised: 24 (PG: 10; CG: 14)
Analysed: 24
Rehab: 10
Control: 14

Interventions

Pulmonary rehabilitation: out-patient programme (hospital-based PR)

Aerobic exercise, ULE, LLE

Duration: 8-Week programme 3 days per week in groups of 2 or 3

Usual care: Control group received optimal care, as suggested by the American Thoracic Society

Outcomes

Assessment:

baseline and Immediately after PR (8 weeks)

Spirometry, Beck Depression Inventory, State Trait Anxiety Inventory, MRC Scale, SGRQ

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot informed
Allocation concealment (selection bias)Unclear riskNot informed
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot informed
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Commenced: 24 (control: 14; intervention: 10)

No loss reported

Selective reporting (reporting bias)High riskNo protocol was identified, but results for the rehabilitation group for CR were not provided
Other biasLow riskNone noted

Petty 2006

Methods Study design: RCT (3 groups): randomised tailored videotape, standard videotape, control
Participants

Setting: physician referrals from private offices, the Denver office of Kaiser Permanente

and the Denver Veterans Affairs Medical Center

Inclusion criteria:

  • Diagnosis of COPD, emphysema or chronic bronchitis; FEV1 < 50% and predicted ratio FEV1/FVC < 70%

  • Stable state

Exclusion criteria:

  • Terminal condition such as late-stage lung cancer

  • Active involvement in a formal pulmonary rehabilitation programme

Participant status:

Age (years ± SD): RG: [customised video: 68.8 ± 9.2; standard video: 68.4 ± 9.0]; CG: 66.8 ± 9.9

Gender (M): RG:[customised video: 39 (54.2%); standard video: 41 (59.4%)]; CG: 40 (54.8%)

Current smoker: RG:[ customised video: 10 ± 14.3%); standard video: 18 ± 26.5%]; CG: 22 ±30.1%

Participants randomly assigned:

Randomised: 214 (customised video: 72; standard video: 69; control: 73)

Analysed:
Rehab: customised video: 52; standard video: 62
Control: 61

Interventions

Pulmonary rehabilitation: home-based programme (in home): a tailored videotape (Group A) and a standard videotape (Group B)

Aerobic exercise, ULE, LLE, educational material, home physio visits

Duration: 8 weeks

Usual care

Outcomes

Assessment:

baseline and 8 weeks

Fatigue Impact Scale (FIS), Seattle Obstructive Lung Questionnaire (SOLQ), SF-36,

6MWD

NotesData could not be analysed, as full results were not available
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomly assigned to 1 of 3 groups in a blocked fashion to achieve balance
Allocation concealment (selection bias)Unclear riskNot known
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Low riskSelf-completion by participants
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Randomly assigned: 214; completed: 174

Attrition: 40 (19%)

Selective reporting (reporting bias)High risk

No protocol was identified

Results of the 6-minute walk test and SF-36 not presented

Other biasUnclear riskNone noted

Reardon 1994

Methods Study design: RCT (2 groups)
Participants

Setting: out-patient; Connecticut

Inclusion criteria:

  • Clinical diagnosis of moderately severe to severe COPD

  • Significant exertional dyspnoea despite conventional medical therapy

Exclusion criteria:

  • Significant associated medical problems that might interfere with ability to undergo OPR

  • Requiring continuous low-flow oxygen therapy

Participant status:

Age (yearsn): RG: 66.3; CG: 66.1

Gender (M/F): RG: 5/5; CG: 5/5

FEV1 % (pred ± SD): RG: 35% ± 10; CG: 33% ± 15

Participants randomly assigned:

Randomised: 20
Analysed:
Rehab: 10
Control: 10

Interventions

Pulmonary rehabilitation: outpatient

LLE, ULE, BE, Edu, Psy
Duration: 6 weeks (12 three-hour sessions)

Usual care: session with the OPR nurse clinician for optimisation of pulmonary therapy

Outcomes

Assessment:

baseline and 6 weeks

ITT, BDI/TDI, 12MWD

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation process: random numbers table
Allocation concealment (selection bias)Unclear riskNot informed
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessments: blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo participant loss after allocation
Selective reporting (reporting bias)Low riskNo trial registration protocol was found at www.controlled-trials.com/mrct/ or www.who.int/trialsearch (searched for author names and parts of title of paper or intervention). However it would seem that all outcomes stated in the study were measured
Other biasLow riskNone noted

Ringbaek 2000

Methods

Study design:

RCT (2 groups)

Randomisation process: sealed envelopes

Outcome assessments: blinded

Participants

Setting: delivered as an outpatient programme in Denmark

Inclusion criteria:

  • Stable COPD with FEV1/FVC ratio 570%, FEV1 > 0.6

  • Age < 75 years

  • Oxygen saturation without oxygen supply > 90%

Exclusion criteria:

  • In an exercise programme

  • Had another serious disease, such as cancer

  • Had home oxygen therapy

  • Were senile or suffered from a psychiatric disorder, or were dependent on walking equipment

Participant status:

Age (years ± SD): RG: 61.8 ± 6.8; CG: 64.6 ± 7.7

Gender (M/F): RG: 1/23; CG: 6/15

FEV1 % (pred ± SD): RG: 49.5 ± 17.4; CG: 44.3 ± 3.7

Current smoking: RG: 16; CG: 7

Participants randomly assigned:
Randomised: 45 (RG: 24; control: 21)
Analysed:
Rehab: 17
Control: 19

(130 approached; 45 randomised)

Interventions

Pulmonary rehabilitation: out-patient (hospital)

Aerobic, LLE, ULE, education, nutritional support
Duration: 8 weeks, 2 sessions a week of 2 hours

Usual care: conventional community care

Outcomes

Assessment:

baseline and 8 weeks

6-Minute WT, SGRQ, Psychological General Well-being (PGWB), Borg Scale

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation process: sealed envelopes
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessments: blinded
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Overall commenced: 45; finished: 36 (84.4%)

Overall attrition: 7 (15.6%)

Selective reporting (reporting bias)Low riskNo trial registration protocol was found at www.controlled-trials.com/mrct/ or www.who.int/trialsearch (searched for author names and parts of title of paper or intervention). However it would seem that all outcomes stated in the study were measured
Other biasLow riskNone noted

Simpson 1992

Methods Study design: RCT (2 groups), stratified
Participants

Setting: out-patient

Inclusion criteria:

  • Clinically stable state, no recent infective exacerbation

  • Drug management considered to be optimal

  • FEV1/VC < 0 7

  • Body weight within 30% of predicted ideal body weight

Exclusion criteria:

  • NOT clinically stable state

  • Recent infective exacerbation

  • Disorders likely to affect exercise and capacity to participate

Participant status:

Age (years ± SD ): RG: 73 ± 4.8; CG: 70 ± 5.7

Gender (M/F): RG: 5/9; CG: 10/4

FEV1 % (pred ± SD): RG: 39.5 ±18.96; CG: 39.2 ± 21.39

FEV1/FVC: RG: 49.4 (12.95); CG: 47.8 (14.04)

Participants randomly assigned:

Randomised: 34
Analysed:
Rehab: 14
Control: 14

Interventions

Pulmonary rehabilitation: Weight-lifting programme training was prescribed for upper and lower limb muscles; resistance was increased progressively

LLE, ULE
Duration: 8 weeks 3 times a week

Usual care: Control group attended only for testing

Outcomes

Assessment:

baseline and 8 weeks

6MWT, ICET, SSCET, CRQ

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation process: coin toss
Allocation concealment (selection bias)Unclear riskNo information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessments: blinded for CRQ, not blinded for the others
Incomplete outcome data (attrition bias)
All outcomes
Low risk

28/34 completed = 82.3%

Attrition: 17.64%

Selective reporting (reporting bias)Low riskNo trial registration protocol was found. However it would seem that all outcomes stated in the study were measured
Other biasLow riskNone noted

Singh 2003

Methods

Study design:

RCT (2 groups)

Participants

Setting: home based, carried out by Department of Medicine, SMS Medical College and Hospital, Jaipur, India

Inclusion criteria:

  • Stable patients

  • Chronic bronchitis and/or emphysema with FEV/FVC ratio < 0.7 and FEV1

  • Less than 40% of predicted

  • Dyspnoea in 3 or more daily activities

  • Given up smoking for at least 2 months

Exclusion criteria:

  • Involved in a pulmonary rehabilitation programme

  • Right ventricular failure, unstable ischaemic heart disease

  • Oxygen saturation < 88% at rest

  • Musculoskeletal disease, acute exacerbation and pneumothorax

Participant status:

Age (years ± SD): 59.3 ± 6.4

Gender (M/F): male 32 (80%), female 8 (20%)

FEV1 % (pred ± SD ): RG: 28 ± 7.5; CG: 26 ± 7.1

FEV1/FVC (±SD): RG: 44 ± 16; CG: 48 ± 10.4

Participants randomly assigned:
Randomised: 40
Analysed:
Rehab: 20
Control: 20

Interventions

Pulmonary rehabilitation: domiciliary pulmonary rehabilitation for 4 weeks;

supervised weekly to ensure that participants were following the rehabilitation schedule properly and were taking regular treatment

LLE, IMT
Duration: 4 weeks 30 minutes twice a day

Usual care: Control group participants were asked to continue their activities as usual

Outcomes

Assessment:

baseline and 4 weeks

CRQ, 6MWT

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation process: random numbers table
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskOutcome assessments: not reported
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo attrition
Selective reporting (reporting bias)Low riskAll outcomes appearing in the controlled trial registry (clinicaltrials.gov) seem to have been reported on in the paper
Other biasLow riskNone reported

Sridhar 2008

Methods

Study design:

RCT (2 groups)

Participants

Setting: community and hospital care in West London

Inclusion criteria:

  • Patients who had been discharged with a diagnosis of acute exacerbation of COPD as primary cause of admission

Exclusion criteria:

  • Significant comorbidity such as severe heart disease or cancer

  • Any condition that would preclude participation in the physical therapy component

Participant status:

Age (years ± SD ): RG: 69.9 ± 9.6; CG: 69.68 ± 10.4

Gender (M/F): RG: 30/31; CG: 30/31

FEV1 % (pred ± SD): RG: 42.9 ±15.5; CG: 48.9 ± 18.69

FEV1/FVC: RG:CG

Current smoker (Y/N): RG: 18/61; CG: 12/61

Participants randomly assigned:

Randomised: 122
Analysed:
Rehab: 47
Control: 40

Interventions

Pulmonary rehabilitation: outpatient followed by home package

Aerobic exercise, ULE, LLE, educational material, home physio visits

Duration: 4 weeks, 2 attendances per week (1 hour of education, 1 hour of physical training)

followed by 3 monthly home visits

Usual care: Control group received usual care from primary care physician

Outcomes

Assessment:

baseline and 6 months

CRQ, hospital readmission rate

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomly assigned with the use of random numbers to intervention or control group
Allocation concealment (selection bias)Unclear riskNot informed
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskOutcome assessments: not reported
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Commenced: 122; outcome data for 104

Attrition: 18 (15%)

Selective reporting (reporting bias)Low riskNo trial registration protocol was found. However it would seem that all outcomes stated in the study were measured
Other biasUnclear riskNone reported

Strijbos 1996

Methods

Study design:

RCT (3 groups)

Participants

Setting: out-patient

Inclusion criteria:

Exclusion criteria:

Participant status:

Age (years ± SD ): RG: 61 ± 6 ; CG: 63 ± 5

Gender (M/F): RG: 14/1; CG: 12/3

FEV1 % (pred ± SD): RG: 40.4 ±19.6; CG: 42.6 ± 8.8

Participants randomly assigned:

Randomised: 32

Analysed:
Rehab: 15
Control: 15

Interventions

Pulmonary rehabilitation: hospital-based outpatient pulmonary rehabilitation

programmes (HRPa) are compared with those of a 12-week home care rehabilitation programme

(HCRP)

LLE, BE, PD, Edu, Psy
Duration: 12 weeks twice a week for 1-hour session

Usual care: Control group received no rehabilitation therapy

Outcomes

Assessment:

baseline, 3 months, 6 months, 12 months and 18 months

4-Minute WT, ICET, interviews

NotesUtilised 3-month results for analysis
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskLottery procedure used to determine which group participants allocated to.
Allocation concealment (selection bias)Unclear riskNo information related to allocation concealment provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessments: blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskStarted 50; finished 45; attrition at 3 months: 5 (10%)
Selective reporting (reporting bias)Low riskNo trial registration protocol was found. However it would seem that all outcomes stated in the study were measured
Other biasLow riskNone noted

Theander 2009

Methods

Study design:

RCT (2 groups)

Participants

Setting: pulmonary out-patient department in a central county district of Sweden

Inclusion criteria:

  • 75 years of age or younger

  • FEV1 between 60% and 25% predicted after bronchodilatation

Exclusion criteria:

  • Disabling or severe disease other than COPD

  • Impaired pulmonary function due to other disease

  • Long-term oxygen therapy

  • Alpha1-antitrypsin deficiency, cancer disease, untreated obstructive sleep apnoea syndrome, no COPD-related symptoms affecting activities of daily life

Participant status:

Age (years): RG: 66; CG: 64

Gender (M/F): RG: 3/9; CG: 10/4

FEV1 % (pred ± SD): RG: 35.1 ± 7.6; CG: 32.3 ± 9.5

Smokers: 3 in each group currently smoking

Participants randomly assigned:

Randomised: 30
Analysed:
Rehab: 12
Control: 14

Interventions

Pulmonary rehabilitation: out-patient programme (hospital based followed by home based), multi-disciplinary; comprising a physiotherapist, a dietician, an occupational therapist and a nurse. After 1 month, individualised home exercise added

Aerobic exercise, ULE, LLE, breathing exercises, educational material, nutrition

Duration: 12 weeks 2 days per week,1 hour long

Usual care: Control group received none of the multi-disciplinary rehabilitation programmes and no care from multi-disciplinary professionals

Outcomes

Assessment:

baseline and 12 weeks

6MWD, SQRQ, hand grip strength and health perception, fatigue, functional limitations due to fatigue, functional performance and satisfaction

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation procedures were performed by an independent person from the research group, who took a random envelope from the prepared box with sealed envelopes
Allocation concealment (selection bias)Low riskFor this purpose, we prepared 80 sealed opaque envelopes with assignment information
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
High riskData collection was performed by members of the rehabilitation group. Data collected were not blinded to the data collector
Incomplete outcome data (attrition bias)
All outcomes
Low risk

26/30 complete data for analysis

4/30 lost to follow-up = 13.33%

Selective reporting (reporting bias)Low riskNo trial registration protocol was found. However it would seem that all outcomes stated in the study were measured
Other biasLow riskNone noted

Vallet 1994

Methods Study design: RCT (2 groups)
Participants

Setting: in-patient; France

Inclusion criteria:

  • Diagnosis of COPD

  • Obstruction not reversible

  • History smoking 30 packs/y on average

Exclusion criteria:

  • Heart failure

  • PaO2 ≤ 60 mmHg or with hypercapnia

  • Current infection

Participant status:

Age (years ± SD ): RG: 59.6 ± 2.75; CG: 58.2 ± 1.8

Gender (M/F): RG: 7/3; CG: 8/2

FEV1/FVC: RG: 57.2; CG: 55.7

Participants randomly assigned:

Randomised: 22
Analysed:
Rehab: 10
Control: 10

Interventions

Pulmonary rehabilitation: in-patient rehabilitation

LLE, BE
Duration: 8 weeks

Usual care

Outcomes

Assessment: baseline and 2 months

ICET
QoL: not measured

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Randomisation process: drawing lots

Outcome assessments: not blinded

Allocation concealment (selection bias)Unclear riskNo information related to allocation concealment provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome assessments: not blinded
Incomplete outcome data (attrition bias)
All outcomes
Low risk18/20 (90%) completed
Selective reporting (reporting bias)Low riskNo trial registration protocol was found. However it would seem that all outcomes stated in the study were measured
Other biasLow riskNone noted

Van Wetering 2010

Methods

Study design:

RCT (2 groups)

Participants

Setting:

Inclusion criteria:

  • Impaired exercise capacity

  • Stage 2 or 3 COPD

  • Willing to participate in a community-based programme

Exclusion criteria:

  1. Prior rehabilitation

  2. Serious co-morbidity that precluded exercise therapy ·

  3. Lack of motivation to participate in the treatment programme

Participant status:

Age (years ± SD): RG: 65.9 ± 8.8; CG: 67.2 ± 8.9

Gender (M/F): 71% male in each group

FEV1 % (pred ± SD): RG: 58 ±17; CG: 60 ±15

FEV1/FVC: RG: 49 ±11; CG: 36.1 ± 26.4

Current smokers (%): RG: 33%; CG: 24%

Participants randomly assigned:

Randomised: 199
Analysed:
Rehab: 87
Control: 88

Interventions

Pulmonary rehabilitation: community (primary care setting)

Standardised supervised rehabilitation phase and a 20-month active maintenance phase

Aerobic exercise, ULE, LLE, educational material

Duration: Initally 4-Month, followed by 20-month active maintenance phase (twice a day during 30 minutes)

Usual care: received pharmacotherapy according to

accepted guidelines

Outcomes

Assessment:

baseline and 4 months (immediately after initial intervention)

SGRQ, cycle endurance test (CET), 6MWD, muscle strength (handgrip force

(HGF), isometric quadriceps peak torque (QPT), maximal

inspiratory mouth pressure (Pimax)), 17 body composition (FFM)

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCare provided through a computerised procedure with concealed participant allocation
Allocation concealment (selection bias)Low riskProgramme or usual care through a computerised procedure with concealed participant allocation
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAll measurements were assessed single-blind
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Loss = 24 (12%) (intervention: 15 (4.7%); control: 9 (9.2%))

88% completed, so 12% attrition

Selective reporting (reporting bias)Low riskFrom protocol paper (http://clinicaltrials.gov/ct2/show/NCT00840892), outcomes matched those in the protocol paper
Other biasLow riskNone noted

Vijayan 2010

Methods Study design: RCT (2 groups)
Participants

Setting: India

Inclusion criteria:

  • Moderate to severe, as per GOLD guidelines.

  • 8 weeks on standard inhalational therapy

  • 4 weeks post exacerbation

Exclusion criteria:

Participant status:

Age (years): not provided

Gender: not provided

FEV1 %: not provided

FEV1/FVC: not provided

Participants randomly assigned:

Randomised: 31 (15 control; 16 intervention)
Analysed:
Rehab: 16
Control: 15

Interventions

Pulmonary rehabilitation: not informed of venue

Aerobic exercise, ULE, LLE

Duration: 8 weeks (5 days a week for 90 minutes)

Usual care: Both groups had medication adjusted for 8 weeks

Outcomes

Assessment:

baseline

6-Minute walk test (Only relevant test)

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo Information
Allocation concealment (selection bias)Unclear riskNo details provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo details provided
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo attrition reported
Selective reporting (reporting bias)Unclear riskInsufficent details provided
Other biasHigh riskVery superficial information available in relation to the study, precluding good quality assessment

Weiner 1992

Methods

Study design:

RCT (3 groups): SIMT group received threshold inspiratory muscle trainer and exercise programme, exercise training group and control

randomly matched to 3 groups according to the

following criteria: age; FEV1; and FEV1/FVC

Participants

Setting: out-patient; Isreal

Inclusion criteria:

  • Spirometric evidence of chronic airflow limitation that was not corrected by bronchodilator therapy

Exclusion criteria:

Participant status:

Age (years ± SD): RG: 64.4 ± 3; CG: 62.3 ± 2.4

Gender (M/F): RG: 6/6; CG: 5/7

FEV1 % (pred ± SD): RG: 32.8 ± 3; CG: 39.2 ± 2.8

Participants randomly assigned:

Randomised: 24
Analysed:
Rehab: 12
Control: 12

Interventions

Pulmonary rehabilitation: out-patient (hospital)

Performed under the supervision of a physiotherapist

LLE, ULE, IMT, BE
Duration: 6 months, 3 times a week, each session consisting of 1 hour of training

Usual care: no additional treatment

Outcomes

Assessment:

baseline and 6 months

12-Minute WT, ICET, SSCET
QoL: not measured

Notes1 exercise only group used in the analysis
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation process: random numbers table
Allocation concealment (selection bias)Unclear riskNo information related to allocation concealment provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessments: blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up
Selective reporting (reporting bias)High riskNo trial registration protocol was found. Results of SGRQ not available
Other biasLow riskNone noted

Wen 2008

Methods

Study design:

RCT (3 groups)

High-intensity group

Anaerobic threshold group

Control group

Participants

Setting: out-patient clinic in China

Inclusion criteria:

  • Diagnosis of COPD based on GOLD guidelines

Exclusion criteria:

  • Suffered from disability of lower extremity, serious cardiovascular disease (including unstable angina pectoris, uncontrolled congestive heart failure, acute myocardial infarction, uncontrolled hypertension, frequent premature atrial or ventricular contraction, severe pulmonary hypertension), postexercise syncope

  • Severe disorder of hepatic and renal function

  • Cognitive learning disability and mental illness

Participant status:

Age (years± SD): RG: [ATG: 67 ± 7; HIG: 68 ± 7]; CG: 66 ± 10

Gender (M/F): all male with exception of 1

FEV1% (pred ± SD): RG:[ ATG: 46 ± 10; HIG: 50 ± 14;] CG: 52 ± 14

Participants randomly assigned:

Randomised: 41 (high-intensity group: 17; anaerobic threshold group: 15; control group: 9)

Analysed:
Rehab: High-intensity group: 17; anaerobic threshold group: 15
Control: 9

Interventions

Pulmonary rehabilitation: bicycle exercise training

Aerobic exercise, LLE

Duration: 12 weeks, 2 days a week

Usual care

Outcomes

Assessment:

baseline and 12 weeks

SGRQ, Borg/Max Oxygen Intake

NotesNo results available for the SGRQ
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo Information
Allocation concealment (selection bias)Unclear riskNo details provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo details provided
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

54 randomly assigned, 13 lost

Attrition: 24%

Selective reporting (reporting bias)Low riskNo trial registration protocol was found. However it would seem that all outcomes stated in the study were measured
Other biasLow riskNone noted

Wijkstra 1994

Methods Study design: RCT (2 groups), stratified
Participants

Setting: home based

Inclusion criteria:

  • Clinically stable condition (no recent exacerbations)

  • Optimal drug management.

  • FEV1 < 60% predicted; FEV1/vital capacity (IVC) < 50%; after bronchodilator

Exclusion criteria:

  • Evidence of ischaemic heart disease, intermittent claudication

  • Musculoskeletal disorders or other disabling diseases that could restrict the rehabilitation programme

Participant status:

Age (years ± SD): RG: 64 ± 5; CG: 62 ± 5

Gender (M/F): RG: 23/5; CG: 14/1

FEV1% (pred ± SD): RG: 44 ± 11; CG: 45 ± 9

FEV1/FVC (± SD): RG: 39 ± 8; CG: 36 ± 7

Participants randomly assigned:

Randomised: 45 (RG: 30; CG: 15)
Analysed:
Rehab: 28
Control: 15

Interventions

Pulmonary rehabilitation: out-patient clinic and home based: progressive physiotherapy programme

LLE, ULE, IMT, BE, Edu, Psy, nurse home visited
Duration: 12 weeks, twice a week

In addition, participants had to practice twice a day for half an hour

at home

Usual care: Control group did not follow the above mentioned protocol

Outcomes

Assessment:

baseline and 12 weeks

6-Minute WT, ICET
CRQ

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation process: stratified randomisation
Allocation concealment (selection bias)Unclear riskNo details provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
High riskNot blinded
Incomplete outcome data (attrition bias)
All outcomes
Low risk

43/45 = 95.6% completed

Attrition rate: 4.4%

Selective reporting (reporting bias)Low riskNo trial registration protocol was found. However it would seem that all outcomes stated in the study were measured
Other biasLow riskNone noted

Xie 2003

  1. a

    6MWT: six-minute walk test; BDI/TDI: baseline dyspnoea index/transition dyspnoea index; BE: breathing exercises; CRQ: Chronic Respiratory Disease Questionnaire; Edu: education; IAET: incremental arm ergometer test; ICET: incremental cycle ergometer test; IMT: inspiratory muscle training; ITT: incremental treadmill test; LLE: lower limb exercise; NEADL: Nottingham Extended Actvities of Daily Living scale; PD: postural drainage; POMS: profile of mood state; Psy: psychological support; QoL: quality of life; SGRQ: St. George's Respiratory Questionnaire; SIP: sickness impact profile; SSCET: steady-state cycle ergometer test; SSTT: steady-state treadmill test; ULE: upper limb exercise; WT: walk test; HADS: Hospital Anxiety Depression Scale.

Methods

Study design:

RCT (2 groups)

Participants

Setting: home-based affiliated central hospital of Jilin Medical College, China

Inclusion criteria:

  • Diagnosing standard for chronic obstructive pulmonary disease established by the respiratory branch of the Chinese Medical Association

Exclusion criteria:

  • Ischaemic heart disease, severe uncontrolled hypertension, alteration in thoracic cage

  • Neuromuscular disorders or intermittent claudication or osteoarticular lesions in lower extremities that would affect mobilisation

Participant status:

Age (years± SD): RG: 54 ±6; CG: 54 ± 6

Gender (M/F): RG: 22/3; CG: 21/4

FEV1% (pred ± SD): RG: 41.8 ± 15; CG: 40 ± 16.5

FEV1/FVC(±SD): RG: 40.3 ± 9.3; CG: 42.3 ± 12.1

Participants randomly assigned:

Randomised: 50
Analysed:
Rehab: 25
Control: 25

Interventions

Pulmonary rehabilitation: 1 home rehabilitation walking programme; training intensity was individually determined

LLE
Duration: 12 weeks, 6 days a week, duration of 1 hour

Usual care: Control group participants (medical treatment alone) also made visits to the hospital every 2 weeks for clinical checkup

Outcomes

Assessment:

baseline and 12 weeks

ICE, SWT, dyspnoea, lung function, blood gas

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation process: random numbers table
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskAs a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskOutcome assessments: not reported
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo mention of attrition
Selective reporting (reporting bias)Low riskNo trial registration protocol was found. However it would seem that all outcomes stated in the study were measured
Other biasLow riskNone noted

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
  1. a

    COPD: chronic obstructive pulmonary disease; FEV1: forced expiratory volume in one second; NETT: National Emphysema Treatment Trial; PR: pulmonary rehabilitation.

Akinci 2011Not a randomised controlled trial
Ambrosino 1981Experimental group did not receive exercise training
Ambrosino 2006Control group does not receive 'usual care'
Amin 2011Control group does not receive 'usual care'
Arnadottir 2001Control group does not receive 'usual care'
Backer 2003Control group does not receive 'usual care'
Bauldoff 1996Control group does not receive 'usual care'
Bauldoff 2002Wrong aim
Behnke 2002No control group
Behnke 2002aControl group does not receive 'usual care'
Behnke 2003No control group
Bernard 1999Control group does not receive 'usual care'
Berry 1996Control group does not receive 'usual care'
Bjerre-Jepsen 1981No physical exercise component
Bourbeau 2000No physical exercise component
Bourjeily-Habr 2002No physical exercise component
Breyer 2010Control group does not receive 'usual care'
Brooks 2000Control group does not receive 'usual care'
Böhning 1990Wrong comparison
Cai 2003No physical exercise component
Carrieri-Kohlman 96Control group does not receive 'usual care'
Cegla 2002No physical exercise component
Chen 2011Control group does not receive 'usual care'
Ciric 2008Not a randomised controlled trial
Clark 2000FEV1 higher than 70% of predicted
Cockcroft 1985Control group does not receive 'usual care'
Coppoolse 1999Control group does not receive 'usual care'
Covey 2004Not a randomised controlled trial (review article)
Cox 1993Not a randomised controlled trial
de Blasio 2000Not a randomised controlled trial (editorial)
de Lucas Ramos 1998Experimental group does not receive exercise training
Dekhuijzen 1990Control group does not receive 'usual care'
Dekhuijzen 1991Control group does not receive 'usual care'
Demir-Deriven 2001Control group does not receive 'usual care'
Demir-Deriven 2002Wrong comparison (men compared with women)
Dewse 1998Not a randomised controlled trial (review article)
Di Marzo 2000No physical exercise component
Downes Vogel 2002No physical exercise component
Dushianthan 2009Not a randomised controlled trial (review article)
Egan 2012Not a randomised controlled trial
Ellum 2002Wrong comparison (effect of posture on dyspnoea)
Emtner 1998Not COPD
Epstein 1997Control group does not receive 'usual care'
Esteve 1996Control group does not receive 'usual care'
Fan 2008Control group does not receive 'usual care'
Foglio 2001Control group does not receive 'usual care'
Gadoury 2005Control group does not receive 'usual care'
Gale 2009Not a randomised controlled trial
Garuti 2010Not a randomised controlled trial (review article)
Gautier 1998Control group does not receive 'usual care'
Gautier 2002Control group does not receive 'usual care'
Ghanem 2010Participants not clearly 4 weeks post exacerbation
Gimenez 2000Control group does not receive 'usual care'
Quasi-randomisation
Girodo 1992Not COPD
Goldman 1997FEV1 is higher than 70% predicted
Gormley 1993Control group does not receive 'usual care'
Gosselink 1990Control group does not receive 'usual care'
Green 1999Control group does not receive 'usual care'
Griffiths 1996Control group does not receive 'usual care'
Grosbois 1999Control group does not receive 'usual care'
Gu 2011No physical exercise component
Guell 2006Control group does not receive 'usual care'
Harver 1989Experimental group did not receive exercise training
Hawkins 1999No physical exercise component
Hentschel 2002Control group does not receive 'usual care'
Holland 2003Control group does not receive 'usual care'
Hospes 2009No physical exercise component
Houchen 2011Control group does not receive 'usual care'
Innocenti 2000Control group does not receive 'usual care'
Jensen 1983No physical exercise component
Johnson 2000Control group does not receive 'usual care'
Jungblut 2007Not a randomised controlled trial
Kaplan 1990Control group does not receive 'usual care'
Katsura 2000Control group does not receive 'usual care'
Kurabayashi 1998Experimental group does not receive exercise training
Kurabayashi 2000Experimental group does not receive exercise training
Larson 1999Control group does not receive 'usual care'
Lathlean 2008Randomisation unclear
Laukandt 1998Control group does not receive 'usual care'
Levine 1986Wrong comparison
Lewczuk 1998Not a randomised controlled trial
Li 2002No physical exercise component
Liu 2002Randomisation unclear
Lotshaw 2003Control group does not receive 'usual care'
Ma 2002Control group does not receive 'usual care'
Mador 2002Healthy controls
Mador 2004Control group does not receive 'usual care'
Make 2000Non-randomised comparison
Martinez 1993Control group does not receive 'usual care'
McKeogh 2012Control group does not receive 'usual care'
Morgan 1999Not a randomised controlled trial (review)
Moros Garcia 1996Not randomised
Morris 2003Control group does not receive 'usual care'
MTU 2003Systematic review
Murphy 2004Control group does not receive 'usual care'
Myers 2000Enhancement strategy
Na 2005Not a randomised controlled trial
Nasilowski 2011Not a randomised controlled trial
Nava 1998Unstable patients (wrong population)
Ndundu 2001Case series
Neder 2002Control group does not receive 'usual care'
Newall 2000Control group does not receive 'usual care'
Nguyen 2005Control group does not receive 'usual care'
Ninot 2011Outcomes measured longer than 3 months after the end of the intervention
Nosworthy 1992Control group does not receive 'usual care'
Nygren-Bonnier 2002Control group does not receive 'usual care'
O'Hara 1987Not a randomised controlled trial
Ortega 2002Control group does not receive 'usual care'
Patessio 1994Control group does not receive 'usual care'
Petersen 2008Control group does not receive 'usual care'
Piantadosi 2000No randomised comparison between PR and control group
Pison 2001Not a randomised controlled trial (review article)
Pison 2008Control group does not receive 'usual care'
Pitta 2004Not a randomised controlled trial
Ponsioen 2010Not a randomised controlled trial (review article)
Prince 1989Control group does not receive 'usual care'
Probst 2003Acute effect of walking aid on exercise capacity
Proshchaev 2009Control group does not receive 'usual care'
Puente 19962 types of training compared
Raschke 1990Not randomised
Regiane Resqueti 2007Control group does not receive 'usual care'
Reilly 2000NETT trial does not meet entry criteria for the review
Riario-Sforza 2009Randomisation unclear
Ries 1986Control group does not receive 'usual care'
Ries 1988Control group does not receive 'usual care'
Ries 1995Control group does not receive 'usual care'
Roberts 1999Control group does not receive 'usual care'
Rooyackers 1996Control group does not receive 'usual care'
Rudkin 1997Control group does not receive 'usual care'
Santiworakul 2009Randomisation unclear
Sassi-Dambron 1995Experimental group does not receive exercise training
Saunders 1965No physical exercise component
Scherer 1998Control group does not receive 'usual care'
Scorsone 2010Control group does not receive 'usual care'
Semenyuk 2007No physical exercise component
Serres 1997Inadequate duration (shorter than 4 weeks)
Sewell 2005Control group does not receive 'usual care'
Sinclair 1980Not a randomised controlled trial
Sindhwani 2011Not a randomised controlled trial
Sivori 1998Control group does not receive 'usual care'
Solanes Garcia 2004Randomisation unclear
Sparrow 1997Control group does not receive 'usual care'
Spruit 2001Control group does not receive 'usual care'
Steele 2008Control group does not receive 'usual care'
Stellefson 2009Not an exercise programme
Sudo 1997Control group does not receive 'usual care'
Sugawara 2007Control group does not receive 'usual care'
Sun 2003No physical exercise component
Swerts 1990Control group does not receive 'usual care'
Taylor 2012Not an exercise programme
Toevs 1984Control group does not receive 'usual care'
Troosters 1999Not a randomised controlled trial (review article)
Tsang 2001Control group does not receive 'usual care'
Ubaidullayev 1990No physical exercise component
Vargas 1998No physical exercise component
Vogiatzis 1999Treatment allocation not randomised
Vogiatzis 2001Control group does not receive 'usual care'
Vogiatzis 2002Control group does not receive 'usual care'
Wadell 2005Not a randomised controlled trial
Wadell 2013Control group does not receive 'usual care'
Wanke 1994Control group does not receive 'usual care'
Wedzicha 1998Control group does not receive 'usual care'
Weiner 1992aNot COPD
Wen 2004Participants not clearly 4 weeks post exacerbation and length of intervention unclear
White 2002Control group does not receive 'usual care'
Worth 1985Not randomised
Xu 2010Length of programme unclear
Yamanaka 2009Not a randomised controlled trial
Yan 1996Experimental group does not receive exercise training
Yosbauran 1996Control group does not receive 'usual care'
Zanini 2002Control group does not receive 'usual care'
Zhang 2008No physical exercise component

Characteristics of studies awaiting assessment [ordered by study ID]

Aksu 2006

Methods3 groups
Participants58 participants
Interventions

Pulmonary rehab: aerobic exercise group; aerobic exercise plus isotonic strengthening exercise group; control group with no exercise

Duration: 3 times per week for 12 weeks

Usual care: not known

Outcomes

Assessment: baseline and 12 weeks

Exercise performance (measured by Bruce exercise tolerance test), 6MWT, dyspnoea scores, SGRQ, SF-36, BMI and pulmonary function

NotesNot possible to establish contact with study authors

D'Amico 2010

MethodsNot known
ParticipantsRCT (2 groups)
Interventions

Pulmonary rehabilitation: indoor aerobic training

Duration: 3 days per week, 60 minutes each time, for 6 months

Usual care: not known

OutcomesSpirometry, oxygen saturation, ambulatory blood pressure measurement, health-related quality of life (SF-12)
NotesNot possible to establish contact with study authors

Meshcheryakova 2010

MethodsRCT (4 groups)
Participants57 participants
Interventions

Pulmonary rehabilitation: physical training

Duration: not known

Usual care: standardised medication

Outcomes6-Minute walk test, respiratory muscle strength, health-related quality of life (SF-36), lung function
NotesContact information: m_natalia1967@inbox.ru

Meshcheryakova 2012

MethodsRCT (3 groups)
Participants45 participants
Interventions

Pulmonary rehabilitation: a physical exercise programme

Duration: not known

OutcomesBMI, pulmonary function, 6MWT, shortness of breath, health-related quality of life (SF-36), systemic inflammation blood indicators, blood testosterone, muscle power and depression
NotesContact information: m_natalia1967@inbox.ru

Ren 2011

  1. a

    6MWT: six-minute walk test; BMI: body mass index; COPD: chronic obstructive pulmonary disease; FEV1: forced expiratory volume in one second; RCT: randomised controlled trial; SF: Short Form; SGRQ: St. George's Respiratory Questionnaire.
    Six studies were awaiting classification in the previous version of the review (Corrado 1995; Fernández 1998; Shu 1998; Tregonning 2000; Ward 1999; Wright 2002). The current search yielded no related publications since 2006 to allow us to clarify the status of these studies.

MethodsRCT (3 groups)
Participants89 patients with COPD, divided into groups according to severity of COPD
Interventions

Pulmonary rehabilitation: 2 different programmes used for 20 weeks

Usual care: not known

Outcomes

Assessment: baseline and 20 weeks

6MWT, BODE Index, acute exacerbation frequency, Modified Medical Research Council Scale, BMI and pulmonary function (FEV1)

NotesNot possible to establish contact with study authors

Characteristics of ongoing studies [ordered by study ID]

Chang 2008

Trial name or titlePulmonary rehabilitation or self-management (PRSM) for chronic obstructive pulmonary disease (COPD)
Methods

RCT (3 groups)

Individual randomisation, blinded outcome assessment, 3-monthly follow-up assessments across a 12-month period and concurrent economic evaluation

ParticipantsTarget of 85 per group
InterventionsStanford Chronic Disease Self-Management programme vs multi-factorial pulmonary rehabilitation group vs usual care provided by a GP
Outcomes

Primary outcome measure is St. George's Respiratory Disease Questionnaire

Secondary outcome measures are measured by Frenchay Activities Index, International Physical Activity Questionnaire, the Hospital Anxiety and Depression Scale, the COPD Self-Efficacy scale and 2 physiological measures (forced vital capacity in 1 second and an incremental shuttle walk) measured at baseline and at 3-monthly intervals across 12 months. Also, spirometry and incremental shuttle walk at baseline and at 3 months

Starting dateApril 2008
Contact information terrence.haines@monash.edu
NotesResults not yet published

Gurgun 2011

Trial name or titleEfficacy of an Eight-Week Pulmonary Rehabilitation in COPD Patients: An Experience of a Single Center in Turkey
MethodsRCT (2 groups)
Participants152 stable patients with COPD
Interventions8-Week pulmonary rehabilitation programme vs usual care
Outcomes

Assessment: at 8 weeks

Walking distance, perceived dyspnoea, health-related quality of life, anxiety and depression

Starting dateNot known
Contact informationalev.gurgun@ege.edu.tr
NotesStudy still recruiting at the time of this review

Sathyapala 2008

  1. a

    One ongoing study in the previous version of the review (Whiteford 2004) remains unpublished.

Trial name or titleComparison of Repetitive Magnetic Stimulation (rMS) and Exercise Versus No Active Treatment on Quadriceps Function in Chronic Obstructive Pulmonary Disease (COPD)
MethodsRCT (3 groups)
Participants58
Interventions

Pulmonary rehabilitation: supervised 2-hour resistance and endurance exercise programme twice a week for 8 weeks

Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks

Usual care: no intervention

Outcomes

Assessment at 8 weeks

Lung function, fat-free mass, quadriceps strength, locomotion time and movement intensity over a 2-day period

Starting date2007
Contact information m.polkey@imperial.ac.uk
NotesResults not yet published